
project engineer London, England
Job description
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.
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.
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
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.
