European Lead, Commissioning & Qualification
We are currently sourcing a European Lead, Commissioning & Qualification to join our global Engineering team. In this role you will be responsible for setting directions, providing guidance and managing the global commissioning and qualification (C&Q) program for the European (Ireland, Germany & Italy) and Singapore regions.
You will collaborate with the R&D and manufacturing site leadership, and Site Quality teams to drive optimum and standardized C&Q approach across the European network while leading and providing directions and validation strategy for key capital projects in the European region. In addition, you will benchmark with other bio-pharma companies to continue to enhance the overall C&Q program for achieving optimal program outcome
Key Responsibilities Include:
- Collaborate closely with the C&Q Manager in US to set Vision and Strategy for the corporate C&Q program.
- Implement corporate C&Q strategies.
- Identify and implement continuous improvement ideas to enhance the program.
- Assist in development and plan for C&Q budget/estimates and other financial planning.
- Provide leadership and oversight on C&Q for all European sites.
Education & Experience:
- B.S degree in Chemical, Mechanical, or Electrical Engineering
- Masters Degree in Engineering or MBA preferred
- Minimum 10 years of experience in Pharmaceutical/bio-pharmaceutical industry
- Minimum 7 years of experience in leading C&Q programs, and experience with interfacing Regulatory/Quality or auditors
- Minimum 5 years of experience with supervisory, project management and budget management are required
- Leadership of other technical professionals and experience in leading cross-functional teams with results-orientation. Skilled in the strategy development, initiation, selection, coordination and management of projects and have ability to solve unique problems.
- Knowledge of regulations and standards affecting devices, biologics and pharma products. Strong working knowledge of ICH, ISO, US CFR and EU regulations.
- Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM
- Strong interpersonal and communication skills (verbal/written)
- Strong negotiation skills
Primary Location: Ireland-Leinster-Santry
Travel: Yes, 25 % of the Time
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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