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 a Project Manager to join our growing operations in the UK. We are currently targeting PMs for roles in the London, Cambridge and Swindon areas. The role of a PM 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.
· Coordinate support during C&Q execution
Position Requirements:
· BS or MS in a relevant science or engineering field, or equivalent
· 8 + years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences or Regulated Industries; Sound technical knowledge of UK, EU and global regulatory requirements. Proficient in cGMP standards.
· Experience in collaborating and managing Commissioning, Qualification and Validation deliverables for one or Multiple Projects
· 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.
· Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
· Able to travel domestically and internationally if required.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 900 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 CSV Engineers to join our growing operations in the UK. The role of a CSV Engineer in CAI is to:
• 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:
• Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
• Experience in a GMP environment essential.
• Excellent oral and written communication skills
• Excellent problem-solving skills
• Customer-service focused.
• Able to travel domestically and internationally if required.
#LI-Hybrid
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 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.
This Mechanical Engineer Lead performs mechanical systems testing in compliance with a project schedule. The mechanical engineer should have a working knowledge of mechanical P&IDs, electrical one-line drawings and a general understanding of mechanical systems: Mechanical (HVAC) systems, air distribution (fans, ducting, VAVs), refrigeration systems, chilled water systems, hot water heating systems, steam heating systems and fire protection equipment. He/she will drive the functional performance test for each mechanical system assigned and is expected to be able to competently follow approved test scripts. Needs to be self-motivated and willing to actively engage contractors/vendors to set up testing to complete all required activities for project success
The witness, verification and validation of proper execution of commissioning tests is to be documented by the Mechanical Engineer Lead. The quality of documentation is vital to success of program and the Mechanical Engineer Lead is expected to have knowledge and ability to complete all document requirements and ability to lead project independently.
Responsibilities
· Lead and steer all mechanical commissioning and testing activities for all contracted testing and commissioning work related to mechanical, cooling, HVAC, airflow, water, refrigerant/return piping and plumbing systems (and possibly structural and civil expertise) at the client`s site according to agreed Scope of Works
· Guide technical discussion and clarification with client acting as and advisor/coordinator for any technical, mechanical, cooling, HVAC, airflow, water, refrigerant/return piping and plumbing related topics and in some circumstances structural and civil engineering related topics
· Act as technical expert and advisory for the client, advising on feasibility, practicality and any cost, resource impact of solution, methods and work procedures at all stages of the commissioning process
· Fulfil the role of on-site technical lead and coordinate obtaining correct information from equipment vendors, client, contactors and site owners to make decision and lead
· Participate and contribute to meetings with the client, consultants, other contractors to provide expert technical opinion. Work with all commissioning stakeholders to sign-off and commit to a common and agreed commissioning deliverables scope and outline items
· Ensuring all relevant certification and required documentation have been provided by construction contractors, equipment/system vendors to be approved and used as reference for commissioning documentation development
· Review, check, analyze, and provide opinion on design documents such as BoD, OPR, mechanical, cooling, HVAC, ducting, piping and plumbing drawings, schematics, diagrams and installation drawings as well as approve documents meeting commissioning requirements of the client
· Support engineering and commissioning deliverables development, working together with team members
· Develop, create, review and achieve approval of test scripts, Inspection Test Plans (ITPs)
· Develop, create, review, achieve approval and initiate Factory Acceptance Tests (FAT) or Factory Witness Tests (FWT)according to the needs of the client
· Ensure delivery quality is consistent with testing and commissioning requirement from client and the tested outcome is consistent with the client`s desired specification and performance requirements
· Enforce and work to the client`s project timelines and supervise all mechanical, cooling, ducting, piping and flow/balancing commissioning activities according to the client`s commissioning schedule and timeline
· Steer and guide all stakeholders (general contractors, equipment suppliers, BEP contractors) to achieve commissioning outcomes to the prerequisites of the client BoD and OPR, periodically assessing and evaluating the conformance, progress and suitability of planned work in line with the agreed commissioning deliverables
· Supervising, monitoring all mechanical, cooling, airflow, piping and plumbing commissioning works ensuring the tests are effective for all associated Cx levels
· Facilitating effective handover of equipment, facilities and outcomes from commissioning, ensuring all required certification and associated records, testing/verification documentation have been checked and approved and signed-off from vendors, construction contractors as well as by the company for test performance confirmation
· Check that critical decisions, actions and planning regarding commissioning are shared, reviewed and developed together with the company's global expertise to ensure consistency with the company`s global approach and policy, standards
Critical Skills and Knowledge
· Bachelor degree or equivalent experience
· Knowledge of OSHA safety requirements.
· 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.
Working Conditions
· Extensive travel may be required (75%)
· Work under construction site conditions
#LI-KO1
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 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.
The role:
The Electrical Commissioning Engineer Lead provides direction of all electrical aspects of assigned commissioning projects from initial engagement through turn over to the client. He/she will be expected to execute against the project schedule through the coordination of contractors and/or vendors to complete the desired electrical system testing while ensuring the safety of oneself and other project personnel.
Responsibilities:
· Lead and steer all electrical commissioning and testing activities for all contracted testing and commissioning work related to electrical systems at the client`s site according to agreed Scope of Works.
· Act as technical expert and advisory for the client, advising on feasibility, practicality and any cost, resource impact of solution, methods and work procedures at all stages of the commissioning process.
· Fulfil the role of on-site technical lead and coordinate obtaining correct information from equipment vendors, client, contactors and site owners to make decision and lead.
· Participate and contribute to meetings with the client, consultants, other contractors to provide expert technical opinion. Work with all commissioning stakeholders to sign-off and commit to a common and agreed commissioning deliverables scope and outline items.
· Ensuring all relevant certification and required documentation have been provided by construction contractors, equipment/system vendors to be approved and used as reference for commissioning documentation development.
· Review, check, analyze, and provide opinion on design documents such as BoD, OPR, electrical drawings, schematics, diagrams and installation drawings as well as approve documents meeting commissioning requirements of the client.
· Support engineering and commissioning deliverables development, working together with team members
· Develop, create, review and achieve approval of test scripts, Inspection Test Plans (ITPs)
· Develop, create, review, achieve approval and initiate Factory Acceptance Tests (FAT) or Factory Witness Tests (FWT)according to the needs of the client
· Ensure delivery quality is consistent with testing and commissioning requirement from client and the tested outcome is consistent with the client`s desired specification and performance requirements
· Enforce and work to the client`s project timelines and supervise electrical commissioning activities according to the client`s commissioning schedule and timeline
· Manage the progress of work through task completion progress tracking and regular work completion status updates. Pro-actively and regularly update, provide feedback and communicate on work progress with internal teams, Project Manager and client team on work progress
· Create and develop regular technical reports regarding commissioning project status
· Using expert knowledge to identify and create an informed opinion, clearly and transparently communicate to the Project Manager, Client Manager on issues, opportunities, challenges or risks to project schedule and resourcing during any stage of work
· Track potential changes during job progression and have competency in understanding identifying scope variation (potential scope and requirement changes) and how it affects commissioning schedule, budgeting and initially defined commissioning targets
· Collaborate closely with Project Manager when quantifying any scope variation including any price, budget or resource change and to assist in developing mitigation or contingency plans.
Critical Skills and Knowledge
· Bachelor degree or equivalent experience
· Knowledge of OSHA (or equivalent) safety requirements.
· 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 Electrical Distribution Switchgear, Substations, Uninterruptable Power Sources (UPS), Automatic Transfer Switches (ATS), Batteries, Emergency Diesel Generators & Load Banks.
· Knowledge of power quality analysis
Working Environment:
Extensive travel (75%)
Construction environment
#LI-KO1
Stiamo ricercando un profilo di: Computer Sistem Validation Engineer, preferibilmente locato nella Provincia di Roma.
Summary: This position uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
Essential Duties and Responsibilities include, but are not limited to, the following:
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.Agent expected skills: CSV , IT, GMP based knowledge.
Demonstrated ability with information technology delivery for regulated businesses highly desirable, specifically in supporting IT delivery or transition in manufacturing or integrations. Leadership experience in a matrixed environment preferred.
Ability to balance the long-term ("big picture") and short-term implications of individual decisions
Experience in delivery of successful enterprise level IT programs
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
La selezione rispetta il principio delle pari opportunità (l. 903/77)
#LI-AG1
We are seeking CSV Engineers with 2-5 years' experience and 2 years' experience in GMP environment.
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with 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 (our core values). 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.
Position Description:
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.
Position Requirements:
BS in a Computer Science or Engineering field or equivalent experience
2-7 years’ experience with Computer systems validation
2 years’ experience working in a GMP environment
Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is 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
La selezione rispetta il principio delle pari opportunità (l. 903/77)
#LI-AG1
Position Description:
We are now seeking a CQV Engineer to join our growing operations in Italy. 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.
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
Minimum 4 – 8 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
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.
Available for travel in Italy and abroad.
La selezione rispetta il principio delle pari opportunità (l. 903/77)
#LI-AG1
Position Description:
We are now seeking a CQV Engineer to join our growing operations in Italy. 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.
Position Requirements:
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
Minimum 4 – 8 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
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
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:
expected skills: Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge
Expertise in Microsoft Word and Excel
Excellent oral and written English are required.
Available for travel in Italy and abroad.
La selezione rispetta il principio delle pari opportunità (l. 903/77)
Position Description:
We are now seeking a CQV Engineer to join our growing operations in Italy. 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.
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
Minimum 4 – 8 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
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.
Available for travel in Italy and abroad.
La selezione rispetta il principio delle pari opportunità (l. 903/77)
#LI-AG1
Position Description:
We are now seeking a CQV Engineer to join our growing operations in Italy. 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.
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
Minimum 2 – 5 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
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.
Available for travel in Italy and abroad.
La selezione rispetta il principio delle pari opportunità (l. 903/77)
#LI-AG1
“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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