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Contact Info
James Cassidy
Life Science

+353 1 5079250
james.cassidy@lifescience.ie
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Details

European Lead, Commissioning & Qualification


Reference:JCARQG-420181 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Engineering Manager

European Lead, Commissioning & Qualification

Our client a global, research-based biopharmaceutical company are currently sourcing a European Lead, Commissioning & Qualification to join their global Engineering team. Successful candidate 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.

Commissioning and Qualification Lead 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

Role/Responsibilities:
• 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



James Cassidy | Tel: +353 (0) 1 5079250