One of Ireland's largest vaccines and biologics facility that is focused on formulating and filling vaccine and biologic products are growing there highly-skilled team and building their presence in Carlow so that they can continue to lead scientific breakthroughs in the treatment of some of the world's most harmful diseases.
Role: Commissioning and Qualification Lead
Contract: 12 Month Contract
Hours: 39 Hours per week over 4 day.
- Report to HPV Portfolio Lead / MSD Project Manager on the given project.
- Lead and coordinate a commissioning and qualification program, incorporating Clean Utilities (including CIP), syringe ling, vial line and associated upstream operations.
- Assist the C&Q manager in the planning and tracking of activities.
- Liase with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
- Participation in GMP design reviews (DQ, CIA etc.), as required.
- Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
- Owner of pre-requisite C&Q deliverables (System Impact Assessment, Critical Component Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix).
Education and Experience
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Minimum of 8-12 years' experience in commissioning and/or validation of USP/DSP/Facilities/Utilities systems within Pharmaceutical industry.
- Technical knowledge of utilities, upstream & downstream equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred
- Minimum 5 years of experience with supervisory, project management and budget management are required
This is a great opportunity to join a truly global community in Carlow.
Not sure yet? No CV ready? Give me a call on 01-8883477 for more information
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales