Senior Engineer

2 weeks ago

Limerick, Limerick, Ireland beBeeQualification Full time €90,000 - €110,000
Critical Validation Role

We are seeking a highly skilled engineer to conduct and lead Commissioning, Qualification, Validation team activities with direct regard for Safety.


Key Responsibilities:
  • Conduct and lead commissioning qualification validation activities.
  • Manage documentation execution lifecycle from SLIA generation through to OQ completion.
  • Generate procedures for projects.
  • Approve TOPs.
  • Facilitate planning of commissioning spares and consumables.
  • Deliver C&Q activities as required to meet the schedule.
  • Track progress of C&Q activities.
  • Prepare Qualification Summary Reports QSR and manage Requirement Traceability Matrix RTM.
  • Execute design reviews shakedown commissioning FAT's IQ OQ PQ activities.
  • Manage verification as requested i.e. change controls document control punch list management.
  • Coordinate with contractors vendors to execute required tests.
  • Allocate project resources for efficient execution of project deliverables.

Requirements:
  • 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.
  • Excellent oral 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 internationally if required.

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