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Project Engineer

2 months ago

London, Greater London, United Kingdom Cagents Full time
About CAI

CAI is a 100% employee-owned company that has grown exponentially over the years to become a leading provider of commissioning, qualification, validation, start-up, project management, and consulting services to FDA-regulated and other mission-critical industries.

Our Approach

We put our clients' interests first and strive to deliver exceptional results. Our team is committed to living our Foundational Principles, which include acting with integrity, serving each other, serving society, and working for our future.

We believe that one person's success is everyone's success, and we work diligently to accomplish team goals. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.

Job Summary

We are seeking a highly skilled Project (CQV) Engineer to join our team in the UK. The successful candidate will be responsible for performing commissioning, qualification, and validation team activities with a direct regard for safety.

The ideal candidate will have a strong background in life sciences manufacturing processes, excellent oral and written communication skills, and the ability to travel domestically and internationally if required.

Key Responsibilities
  1. Perform Commissioning, Qualification, Validation team activities with a direct regard for Safety.
  2. Generate C&Q Procedures for projects.
  3. Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents.
  4. Facilitate scoping/planning of commissioning spares and consumables.
  5. Deliver the C&Q activities as required to meet the schedule.
  6. Track progress of C&Q activities as required.
  7. Prepare Qualification Summary Reports (QSR), and manage Requirement Traceability Matrix (RTM).
  8. Execute Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.
  9. Coordinate with project contractors and equipment vendors to execute required tests.
  10. Allocate project resources for efficient execution of project deliverables.
Requirements
  1. BS or MS in a relevant science or engineering field, or equivalent.
  2. 5+ years in CQV SME roles for life sciences – prior filling line (IMA/Optima) experience is desirable.
  3. Excellent oral and written communication skills.
  4. Excellent problem-solving skills.
  5. Customer-service focused.
  6. Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy, or equivalent experience.
  7. Able to travel domestically and internationally if required.
Benefits
  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical/Dental/Vision (In accordance with each countries' applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries' applicable regulations)