A Senior C&Q Engineer is required for a global Biopharmaceutical company in Carlow. This is a state of the art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia and infectious disease. The site is less than ten years old and has been fitted with the most up to date manufacturing technology and best practices and is truly a "state-of-the-art" facility. Site activities include the development of next generation oncology products, Formulation of Vaccines & Biologics, Fill finish / Vial filling, Packaging and Global distribution.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Work with Process Design Managers in the development of Regulatory Design Basis and C&Q Execution Strategy during Concept and Basis of Design phases of projects.
- Support project teams in assessing project level staffing needs to ensure that appropriate C&Q staffing, expertise and leadership (both with internal and external resources) exists to successfully execute projects.
- Facilitate GMP design reviews, design qualification and collaborate on the development of Project Validation Master Plans and execution of Product Quality Risk Assessments
- Provide direct project support for strategic and at risk projects to ensure successful execution of the C&Q strategy
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BS Degree in Chemical/Mechanical Engineering, Biotechnology or equivalent applied life sciences qualifications.
- Post-OQ/Tech Transfer phase - Clean Utility, HVAC/environmental and Process PQ's; cleaning, thermal cycle development and validation; demonstration batch manufacture; operational readiness and maintenance readiness workstreams
- Prior project management knowledge
- ISPE GAMP 5 - Risk Based approach to compliant GxP Computer Systems
- Lean/Six sigma belt certification/experience
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Ellen Farley at LSC on 021-4777329 if you have anymore questions about this C&Q opportunity!