The Project CQV Engineer will manage commissioning, qualification, and validation activities for projects, ensuring safety and compliance while generating and reviewing relevant documentation, and coordinating with contractors and vendors.
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.
Are you Ready?
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.
We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties.
Top Skills
Commissioning
Equipment Design
Installation Qualification
Operation Qualification
Performance Qualification
Qualification
Validation
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