About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 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 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 Project (CQV) Engineers to join our growing operations in the UK. We are currently targeting Project (CQV) Engineers for roles in the London region. The role of a Project (CQV) Engineer in CAI is to:
· Perform Commissioning, Qualification, Validation team activities with a direct regard for Safety.
· Generating C&Q Procedures for projects.
· CQV review/qualify equipment design – filling line (IMA / Optima)
· Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans
· Facilitate scoping / planning of commissioning spares and consumables.
· Deliver the C&Q activities as required to meet the schedule
· Track progress of C&Q activities as required.
· Preparation of Qualification Summary Reports (QSR), and management of Requirement Traceability Matrix (RTM)
· Execution of Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.
· Coordinate with project contractors and equipment vendors to execute required tests.
· Allocate project resources for efficient execution of project deliverables.
· Coordinate support during C&Q execution
Position Requirements:
· BS or MS in a relevant science or engineering field, or equivalent
· 5+ years in CQV SME roles for life sciences – prior filling line (IMA / Optima) experience is desirable
· 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.
Position Description:
The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are 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.
Requirements include:
Position Requirements:
BS in a relevant science or engineering field, or equivalent years of hands on experience
2-4 years’ experience performing commissioning and / or qualification activities in a regulated industry
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
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Other Requirements:
Excellent oral and written English is required
Able to travel domestically and possibly internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 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.
Benefits
Our full time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
Position Description:
The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are 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.
Requirements include:
Position Requirements:
BS in a relevant science or engineering field, or equivalent years of hands on experience
8-12 years’ experience performing commissioning and / or qualification activities in a regulated industry
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
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Experience in planning / directing C&Q activities a plus
Other Requirements:
Excellent oral and written English is required
Able to travel domestically and possibly internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 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.
Benefits
Our full time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
Position Description:
The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are 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.
Requirements include:
Position Requirements:
BS in a relevant science or engineering field, or equivalent years of hands on experience
4-8 years’ experience performing commissioning and / or qualification activities in a regulated industry
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
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Experience in planning / directing C&Q activities a plus
Other Requirements:
Excellent oral and written English is required
Able to travel domestically and possibly internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 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.
Benefits
Our full time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
Position Description:
The Project Manager will provide leadership and management of project teams to successfully deliver scope of work projects in the pharmaceutical manufacturing industry. This person is responsible for identifying and coordinating activities related to a variety of projects including but not limited to construction, commissioning, qualification, IT, engineering, etc. They will be responsible for maintaining budget, building/adhering to a schedule, delegating tasks, communicating effectively, and providing strict scope management. Technical expertise, willingness to complete project tasks, and experience in the pharmaceutical manufacturing industry are highly desired.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent experience
5-7+ years’ experience commissioning and qualifying bio-pharmaceutical facilities, systems, and equipment, with project management experience highly preferred.
Technical experience in one or more practices within the pharmaceutical industry.
Other Requirements:
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 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.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
Position Description:
The Project Manager will provide leadership and management of project teams to successfully deliver scope of work projects in the pharmaceutical manufacturing industry. This person is responsible for identifying and coordinating activities related to a variety of projects including but not limited to construction, commissioning, qualification, IT, engineering, etc. They will be responsible for maintaining budget, building/adhering to a schedule, delegating tasks, communicating effectively, and providing strict scope management. Technical expertise, willingness to complete project tasks, and experience in the pharmaceutical manufacturing industry are highly desired.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent experience
2-4+ years’ experience commissioning and qualifying bio-pharmaceutical facilities, systems, and equipment, with project management experience highly preferred.
Technical experience in one or more practices within the pharmaceutical industry.
Other Requirements:
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 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.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
Position Description:
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. Other responsibilities include planning / coordinating work and directing small teams in document development and / or execution.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent years of experience
4-12 years' experience in commissioning and/or qualification activities in a regulated industry
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
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Experience in planning / directing C&Q activities a plus
Must have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 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.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
Required experience
- Pharma GMPs main regulations knowledge with at least 8 years experience preferably in role of Manufacturing Science and Technology or Process Validation subject matter expert
- Experience in manufacturing of complex pharmaceutical forms such as aseptic process of drug product, lyophilized products, biological products
- Process Validation and Continuous Process Verification
- Filter Validation
- Single use manufacturing systems
- Aseptic Manufacturing and Media simulation study
- experience in Technology Transfer team (at least 3 years)
- Experience in project management in Technology Transfer projects or similar context
- Risk management
- Documentation Management (SOPs, Specification, Records)
- Deviations/Non-conformities management
- Data integrity
- use of statistical tools and software
Other Desired Experience:
- experience in biotechnology/ biosimilar products (Cell and gene therapy; Cell culture expansion, harvest, purification, formulation, fill and finish; Blood plasma fractionation and component purification)
- experience in solid oral pharmaceutical forms
- Product Quality review
- Developing Validation / Verification Master Plans
- Performing formal risk assessments / FMEA
- Change Control
- CAPA process
- Identifying Critical Attributes and Critical Process Parameters
- Commissioning and Qualification
- Developing User Requirements
- Schedule development and execution
- Establishing metrics and leading team to achieve performance goals
- Facilitating meetings
La selezione rispetta il principio delle pari opportunità (l. 903/77)
#LI-AG1
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 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 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 Microbiologist – Senior I to join our growing operations in Europe. This role can be based in either Ireland or Italy and will require travel to both countries. The role of a Microbiologist – Senior I in CAI is to:
· Leads execution of instrument and method validations at customer sites
· Participates in customer meetings.
· Inoculates and reads microbiology validation samples.
· Participates in the writing of protocols, reports, and specifications.
· Trains customer on instrument usage and inoculation technique
· Drives deliverables to completion with structured timelines.
Position Requirements:
· Degree in microbiology, biology, or science-related field with a minimum of 3+ years of management related experience in the Pharmaceutical/Life Sciences industry. Relevant experience can substitute for education.
· Understanding of good documentation practices and general quality laboratory function
· Ability to work independently and manage multiple projects simultaneously.
· Strong attention to detail, organizational skills and drive to be successful.
· Experience with aseptic technique and biological safety cabinets
· Outstanding oral and written communication skills (Interpersonal).
· Strong problem-solving abilities for complex problems and ready to take up challenges.
· Strong customer-service focus.
· Willingness and flexibility to travel throughout Europe and potentially internationally if required.
Stiamo ricercando un Junior CSV Engineers con: 1-3 anni di esperienza e almeno un anno di esperienza nel campo delle GMP. Assunzione a tempo indeterminato, è richiesta disponibilità a trasferte.
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
1-3 years’ experience with Computer systems validation
1 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 a plus
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
#LI-AG1
“El objetivo final de proporcionar un método sólido y seguro para transferir soluciones en la planta de manufactura, ha sido alcanzado y CAI desempeñó un papel importante en esta iniciativa de seguridad.”
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