C&Q Engineer Role Carlow

C&Q Engineer

  • Posted Sep 7, 2021
  • Carlow
  • Contract
  • BBBH24413

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!

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