About CAI
CAI is a 100% employee-owned company established in 1996, with nearly 700 people worldwide.
Meeting a Higher Standard
We put the client's interests first and do not stop until it is right.
Our Foundational Principles
* We act with integrity
* We serve each other
* We serve society
* We work for our future
CQV Engineer Role
The CQV Engineer will be responsible for conducting and leading Commissioning, Qualification, Validation team activities with a direct regard for Safety.
Key Responsibilities:
1. Conduct and lead Commissioning, Qualification, Validation team activities with a direct regard for Safety.
2. Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
3. Generate C&Q Procedures for projects.
4. Approve TOPs.
5. Facilitate scoping / planning of commissioning spares and consumables.
6. Deliver the C&Q activities as required to meet the schedule.
7. Track progress of C&Q activities as required.
8. Prepare Qualification Summary Reports (QSR), and manage Requirement Traceability Matrix (RTM).
9. Execute Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.
10. Manage any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management.
11. Coordinate with project contractors and equipment vendors to execute required tests.
12. Allocate project resources for efficient execution of project deliverables.
13. Coordinate support during C&Q execution.
Position Requirements
Qualifications:
* 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.
Skills:
* 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.
Diversity and Inclusion
We are an equal opportunity employer and proud to employ veterans and promote a diverse culture in our workplace. This job description is not all inclusive and you may be asked to do other duties.