The Senior HVAC and Utilities Engineer at CAI is responsible for reviewing the basic and detailed design of the HVAC / Utilities system. In addition, they are also responsible for generating qualification protocols, protocol execution, field verification and generation of summary reports at the client site. The Senior HVAC and Utilities Engineer is critical in the company’s continued success and growth by providing the services to our clients that are key to our business.
Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organization headquartered in the United States with offices in Singapore, Malaysia, China, South Korea, Australia, Ireland and Puerto Rico. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. Check us out at www.cagents.com.
The HVAC & Utility Commissioning and Qualification Engineer is responsible for:
· reviewing the basic and detailed design of the HVAC and Utilities system.
· commissioning and start-up of HVAC and utilities systems.
· developing commissioning and qualification protocols for utility and HVAC systems.
· executing protocols, troubleshooting issues, field verification and generation of summary reports at the client site.
The successful HVAC & Utility Commissioning and Qualification Engineer must have:
· Bachelor degree or higher in Chemical or Mechanical Engineering.
· Minimum 5 years of experience in HVAC / Utilities commissioning and qualification in pharmaceutical industry.
· Experience with air handling unit design, specification, commissioning, qualification and start-up.
· Experience with utilities such as compressed air, process gas, clean water systems.
· Experience with chillers, chilled water systems, LPHW, glycol systems and plant steam system.
· Familiarity with local building codes for HVAC systems.
· Familiarity with GMP, Pharmacopeial requirements of HVAC and Clean Utility systems.
· MNC Biotech, Pharma project C&Q experience is preferred.
Other requirement:
l Good Knowledge of EU / PICS / FDA GMP
l Be familiar with Microsoft software for document handling such as Word, Excel, Power Point, Visio, Project etc.
l Familiar with Auto CAD for drawing and reviewing.
l Good at English for reading, speaking, writing. Can write English technical documents with English.
l Team worker and keep learner.
l Easy to communicate and willing share.
In return for your skills and knowledge, CAI offers a wide range of benefits including:
· Medical, dental, company paid life insurance and more
· Paid time off
· Continuing education (internal and external)
#LI-KO1
Job responsibilities:
1 Responsible for sampling and testing of water and air conditioning systems. 2. Responsible for drafting validation reports.
3. Responsible for other tasks assigned by the project manager.
Job requirements:
1 College degree or above, undergraduate degree is preferred.
2. Food, Drug, Chemistry, and Automation majors.
3. Have certain English reading and writing skills.
4. Work in an organized and meticulous manner, with a sense of responsibility.
5. Skilled in communicating with others.
About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard:
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
· We act with integrity
· We serve each other
· We serve society
· We work for our future
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking DCx Engineers to join our growing operations in Europe. The role of a DCx Engineer in CAI is to:
· Conduct all mechanical/electrical tests with a direct regards for safety.
· Complete commissioning and performance acceptance testing of the mechanical systems.
· Provide input into mechanical test procedures.
· Document all mechanical test results and analyze for proper adherence to required and industry standards. Documents may include, but not restricted to, commissioning test scripts, event logs, trend data, technical reports and issue logs.
· Coordinate with project contractors and equipment vendors to execute required tests.
· Operate BAS/BMS to develop trend analysis for equipment and overall system response.
Position Requirements:
· BS or MS in a relevant science or engineering field, or equivalent
· 5+ years in Commissioning roles, ideally within the Data Center industry
· Good written and spoken communication skills.
· Ability to read and interpret electrical schematics and mechanical P&IDs.
· Knowledge of mission critical design concepts.
· Knowledge of various Building Automation/Monitoring Systems (BAS/BMS), Air Handlers, Humidifiers, Variable Refrigerant Flow, Computer Room Air Conditioners/Handlers (CRAC/CRAH), Evaporators, Adiabatic Coolers, Pressure/Temperature/Humidity sensors & Flowmeters.
· Knowledge of basic thermodynamics and heat transfer and fluid flow.
· Knowledge of the Test, Adjust and Balance (TAB) process.
· Knowledge of mechanical trend analysis.
· Strong experience with Word, Excel and PowerPoint.
#LI-onsite
About CAI:
CAI was established in 1996, it has grown year over year to more than 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated, Data Centers and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
At CAI, we are committed to living our Foundational Principles, both professionally and personally:
• We act with integrity
• We serve each other
• We serve society
• We work for our future.
We strongly believe that one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Position Summary
Electrical Commissioning Engineer will work as part of the CAI Data Centre / Building Commissioning team and be responsible for the commissioning of mission critical electrical equipment, safe electrical work practices, facility turnover, and issue resolution. Data Centre/ Building Commissioning professionals develop and execute the commissioning tests to demonstrate to the customer that vendor equipment is correctly installed and set to work, support enhanced design reviews, and consult on submission of LEED / Green Star qualification packages.
Responsibilities
· Development of electrical equipment and system test scripts
· Attend and be an active participant of customer equipment FWT/FAT
· Vendor coordination and management
· Perform equipment inspection to ensure build adherence to vendor submittal
· Provide test and documentation that equipment is delivered, installed, and tested correctly and set to function properly for customer
· Support and perform design specification review, manufacturer submittals, one line drawing sets, and project schedule documentation.
· QA/QC of electrical equipment installationstart-up
· Assign test commissioning tasks to electrical commissioning team
· Execute test scripts to confirm equipment and system operation to design specification
· Ensure safe work practices are followed by all on commissioning team and customer site
· Engage with customers to ensure positive experience, goals achievement, and schedule adherence
· Provide daily reports for electrical commissioning team status
· Conduct facility walk downs, turnover, and punch list reviews
· General understanding of LEED specifications and requirements
· Duties may be increased as experience and skill allow
Critical Skills and Knowledge
· BS in an electrical or engineering field or equivalent years’ experience
· 5 years or more of experience in data center commissioning or facility engineering / facility management
· Experience in the following:
> Data Center construction / commissioning
> Electrical switching operations
> Equipment inspections
> Low and/or medium voltage equipment commissioning
> LEED commissioning
> Factory Witness Test / Factory Acceptance Test attendances
> Leading electrical commissioning processes
> Equipment/ facility handover
· Data Center facilities operations experience is desired
· Excellent oral and written communication skills in English
· Able to travel internationally if required. Subject to travel restrictions.
· Candidates must have a Passport or the ability to immediately get a Passport
· Further development training fund will be given to the correct candidate
Working Conditions
· Extensive travel may be required (25-100%)
· May be required to work in other region within or outside of Australia
· Work under construction site conditions
In return for your skills and knowledge, CAI offers a wide range of benefits including:
· Competitive Salary
· Continuing education (internal and external)
· Opportunities to work on cutting edge projects in a highly evolving field
#LI-KO1
CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
About CAI:
CAI is a 100% employee-owned company established in 1996, it has grown year over year to over 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
Position Description:
We are now seeking CSV Engineers to join our growing operations in Australia. The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports. Other duties may include:
• Prepares/reviews validation documentation related to projects/change controls.
• Manages change controls and other compliance related tasks e.g., non-conformances.
• Participates in the review of current and future CSV procedures and polices
• Analyses the results of testing and determines the acceptability of results against predetermined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Participates in regulatory audits and communicates company’s computer validation policies.
• Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
• Manages projects and prepares status reports using Microsoft project and other communication tools.
• May supervise, lead, or manage lower-level personnel.
Position Requirements:
BS in a Computer Science or Engineering field or equivalent experience
Minimum 2-7 years’ experience with Computer systems validation.
Minimum 2-7 years' experience working in a GMP environment.
Experience in Data Integrity with GAMP and 483, compliance, deep 21CFR Part 11 experience highly desired
Experience in biotech and pharma is preferred over medical device.
Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required.
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
High attention to detail.
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
Independent individual and yet a strong team player.
In return for your skills and knowledge, CAI offers a wide range of benefits including:
Highly Competitive Salary
Continuing education (internal and external)
Opportunities to work on cutting edge projects in a highly evolving field.
#LI-JW1
CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
About CAI:
CAI is a 100% employee-owned company established in 1996, it has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
Position Description:
We are now seeking a CQV Engineer to join our growing operations in Australia. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
The role of a CQV Engineer in CAI is to:
Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Responsible for protocol writing and execution (field verification), and development of summary reports at client sites. O
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
3 – 12 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while quickly building and nurturing a project team
Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
Experience in planning / directing C&Q activities
Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
Familiarity with Baseline Guide 5 (Second Edition) a plus
Other Requirements:
Expertise in Microsoft Word and Excel
Excellent oral and written English are required.
Able to travel domestically if required
Able to work in Australia without sponsorship
In return for your skills and knowledge, CAI offers a wide range of benefits including:
Highly Competitive Salary
Continuing education (internal and external)
Opportunities to work on cutting edge projects in a highly evolving field
#LI-JW1
CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
About CAI:
CAI is a 100% employee-owned company established in 1996, it has grown year over year to over 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
Position Description:
We are now seeking a Project Manager to join our growing operations in Australia.
The role of a Project Manager in CAI is to:
- Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
- Managing mid-sized to large projects related to process equipment and clean utilities including start-up and commissioning
- Lead design review, site acceptance and installation of equipment
- Write, Review and Approve CQV documents following established 21 CFR standards, both internally and externally. Document requests could include: Standard Operating Procedures, Impact Assessments, Risk Assessments, Specifications (URS/FRS/DDS), FATs, SATs, IOQ/PQs, Validation Protocols and Commissioning Test Plans
- Support onsite and offsite activities, such as: FATs, SATs, Executions and System Walkdowns
- Management of any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management.
- Allocate project resources for efficient execution of project deliverables.
- Deliver the C&Q activities as required to meet the schedule
- Track progress of C&Q activities as required and update dashboards
- Coordinate support during C&Q execution
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
5 + years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences or Regulated Industries; Sound technical knowledge of TGA and global regulatory requirements. Proficient in cGMP standards.
Experience in collaborating and managing Commissioning, Qualification and Validation deliverables for one or Multiple Projects
Automation PM experience highly desired
Skilled at planning and tracking project activities and schedules
Excellent interpersonal skills to form strong relationships with internal and external clients.
Excellent oral and written communication skills
Excellent problem-solving skills
Customer-service focused.
High attention to detail.
Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
Other Requirements:
Excellent oral and written English are required.
Able to travel internationally or domestically if required.
Able to work in Australia without sponsorship.
In return for your skills and knowledge, CAI offers a wide range of benefits including:
Highly Competitive Salary
Continuing education (internal and external)
Opportunities to work on cutting edge projects in a highly evolving field.
#LI-JW1
CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
About CAI:
CAI is a 100% employee-owned company established in 1996, it has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
Position Description:
We are now seeking a Senior CQV Engineer to join our growing operations in Australia. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
The role of a Senior CQV Engineer in CAI is to:
Develop documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Other responsibilities include planning / coordinating work and directing small teams in document development and / or execution.
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
5 – 12 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while quickly building and nurturing a project team
Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
Experience in planning / directing C&Q activities
Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
Familiarity with Baseline Guide 5 (Second Edition) a plus
Other Requirements:
Expertise in Microsoft Word and Excel
Excellent oral and written English are required.
Able to travel domestically if required
Able to work in Australia without sponsorship
In return for your skills and knowledge, CAI offers a wide range of benefits including:
Highly Competitive Salary
Continuing education (internal and external)
Opportunities to work on cutting edge projects in a highly evolving field
#LI-JW1
CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
About CAI:
CAI is a 100% employee-owned company established in 1996, it has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
Position Description:
We are now seeking a Senior CQV Engineer to join our growing operations in Australia. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
The role of a Senior CQV Engineer in CAI is to:
Develop documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Other responsibilities include planning / coordinating work and directing small teams in document development and / or execution.
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
5 – 12 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while quickly building and nurturing a project team
Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
Experience in planning / directing C&Q activities
Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
Familiarity with Baseline Guide 5 (Second Edition) a plus
Other Requirements:
Expertise in Microsoft Word and Excel
Excellent oral and written English are required.
Able to travel domestically if required
Able to work in Australia without sponsorship
In return for your skills and knowledge, CAI offers a wide range of benefits including:
Highly Competitive Salary
Continuing education (internal and external)
Opportunities to work on cutting edge projects in a highly evolving field
#LI-JW1
CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
About CAI:
CAI is a 100% employee-owned company established in 1996, it has grown year over year to over 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
Position Description:
We are now seeking Validation Engineers to join our growing operations in Australia. The Validation Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. Our Engineers are responsible for protocol writing and execution (field verification), and development of summary reports at client sites.
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
4+ years relevant experience commissioning/validating in an FDA regulated industry
Autoclave / Parts Washer Qualification experience is required
Experience in 1 or more of the following is desired: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc
Excellent technical problem-solving and troubleshooting skills
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently
Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
Other Requirements:
Expertise in Microsoft Word and Excel
Excellent oral and written English are required.
Able to travel domestically and internationally if required.
Able to work in Australia without sponsorship.
In return for your skills and knowledge, CAI offers a wide range of benefits including:
Highly Competitive Salary
Continuing education (internal and external)
Opportunities to work on cutting edge projects in a highly evolving field.
#LI-JW1
“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”
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