- Reference: 45745
- Job Type: Permanent
- Location: Dublin North, Dublin West
- Category: Bio-Pharmaceutical
European Engineer Lead, Commissioning & Qualification
Global BioPharma/Biotech organisation are currently sourcing a European Lead, Commissioning & Qualification to join their global Engineering team. In this role you will be responsibile 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
For a confidential discussion and more information on the role, please contact Mary Mullin on 09064 78104 and email your cv to firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos!