LSC have a great contract opportunity for a Commissioning & Verification (C&V) SME across multiple projects from Concept Design, Detail Design, Procurement, Mechanical Completion through to site Qualification.
As this role supports European based projects, this role encompasses 50% remote working & 50% travel based on business needs.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Serve as the primary Commissioning & Verification (C&V) Subject Matter Expert for specific projects as directed by ASTM E2500 principles and standards and ISPE Baseline Guide, Vol 5, 2nd edition
- Lead and participate in development and execution of complete verification documentation in accordance with Pfizer Quality Standards, cGMP requirements, and approved verification requirements / strategy related to the assigned work streams
- Effectively interact with leadership and partner with GE C&V Leadership, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish most efficient qualification schedules
- Review of technical specification documents, drawings, and vendor design submittals (including FAT, SAT, Verification documentation), with a specific focus on GMP-critical aspects and impact on commissioning & verification
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution
- Minimum 10 years technical experience
- Experience in a pharmaceutical / FDA-regulated manufacturing environment.
- Fluent in German (Oral & Written)
- A solid working knowledge of cGMP and facility/equipment verification requirements
NOTE: Are you currently eligible to work in Ireland? If so, you will need a Stamp 1G or Stamp 4 to apply.
Apply via this advert or contact Ellen Farley at LSC on 021-4777329 if you have anymore questions about this Commissioning & Validation - SME