LSC have a great contract opportunity for a CQV Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
The CQV Engineer will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes used in the production of drug substances. This role ensures that all systems operate as intended and comply with regulatory standards. The CQV Engineer will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of projects.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems.
- Conduct risk assessments and gap analyses to identify critical process parameters and control strategies.
- Develop and execute commissioning plans for new and existing equipment and systems.
- Manage multiple CQV projects simultaneously, ensuring timely completion and adherence to project timelines.
- Experience with commissioning, qualification, and validation of biopharmaceutical equipment and systems (e.g., bioreactors, chromatography systems, filtration systems).
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
- Experience in CQV within the pharmaceutical or biotechnology industry, specifically in drug substance manufacturing.
- Strong understanding of cGMP, FDA, EMA, and other relevant regulatory requirements.
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 Sarah Ninan on 021 4777 329 if you have any more questions about this opportunity!
