CQV/Validation Engineer
3 weeks ago
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 StandardOur 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.
- 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.
Job ResponsibilitiesThe role of a CQV Engineer in CAI is to:
- Conduct and lead Commissioning, Qualification, Validation team activities with a direct regard for Safety.
- Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
- Generate C&Q Procedures for projects.
- Approve TOPs.
- 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.
- Prepare Qualification Summary Reports (QSR), and manage Requirement Traceability Matrix (RTM).
- Execute Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.
- Manage any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management.
- 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.
The ideal candidate should have:
- A BS or MS in a relevant science or engineering field, or equivalent.
- 3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable.
- 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.
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