Senior Validation Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeQualifications Full time €60,000 - €65,000
Validation and Commissioning Expert

About this role

This position involves leading the commissioning, qualification, and validation team in ensuring safety. The successful candidate will be responsible for managing C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.

The ideal candidate will have excellent communication skills, problem-solving skills, and customer-service focus. Proficiency in life science manufacturing processes is also essential.

We put the client's interests first, doing what it takes to get things right. As owners of CAI, we live by our Foundational Principles:

  • We act with integrity,
  • We serve each other,
  • We serve society,
  • We work for our future.

Our collaborative culture ensures that customers benefit from exemplary work across our services.

Job Responsibilities:
  1. Lead Commissioning, Qualification, Validation activities prioritizing Safety.
  2. Oversee the entire C&Q documentation and execution cycle.
  3. Create C&Q procedures for projects.
  4. Approve TOPs.
  5. Facilitate project planning and scoping for commissioning spares and consumables.
  6. Ensure timely delivery of C&Q activities.
  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 various aspects of C & Q verification, including Change Controls, contractors, vendors, document control, punch list management.
  11. Coordinate with project contractors and equipment vendors to execute required tests.
  12. Allocate resources efficiently for project deliverables.
  13. Provide support during C&Q execution.
Requirements:
  1. Bachelor's or Master's degree in a relevant science or engineering field.
  2. At least 3 years of experience in CQV roles for life sciences - Clean Utilities/Filling experience preferred.
  3. Excellent communication and problem-solving skills.
  4. Customer-service focused.
  5. Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
  6. Able to travel domestically and internationally if required.

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