CQV Engineer

2 weeks ago

Limerick, Limerick, Ireland beBeeValidation Full time €90,000 - €120,000
Commissioning, Qualification and Validation Engineer

About Us:

We are a leading provider of commissioning, qualification, and validation services for life sciences companies. Our team of experts works closely with clients to ensure that their facilities and equipment are properly commissioned, qualified, and validated.

Job Description:

We are seeking an experienced Commissioning, Qualification, and Validation (CQV) Engineer to join our team. The successful candidate will be responsible for conducting and leading CQV activities, managing documentation, and ensuring compliance with regulatory requirements.

  • Conduct and lead CQV 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 CQV activities as required to meet the schedule.
  • Track progress of CQV activities as required.
  • Prepare Qualification Summary Reports (QSR), and manage Requirement Traceability Matrix (RTM).

Requirements:

To be successful in this role, you will need:

  • A Bachelor's or Master's degree in a relevant science or engineering field, or equivalent experience.
  • At least 3 years of experience 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.

Benefits:

We offer a competitive salary and benefits package, including:

  • Opportunities for professional growth and development.
  • A collaborative and supportive work environment.
  • A chance to work on exciting and challenging projects.

We are an equal opportunity employer and welcome applications from diverse candidates.

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