LSC have a great contract opportunity for a Validation Engineer to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 3+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process from initial design through qualification to validation maintenance (eg. Periodic review)
- Coordinates the qualification activities and maintain Equipment and utility systems in a validated state
- Development or qualification approaches and equipment family strategies
- Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
- Development and approval of C&Q / Validation Plans, FAT, SAT IV/FTs, QRAES, IOQ's, PQ's etc. for the Vial and Syringe filling, formulation, inspection and clean utility areas in line with GMP's, regulatory requirements and corporate standards.
- Assist in assessment of project change controls ensuring Validation standards & requirements are met.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 3+ years experience in Science, Engineering or Validation, Commissioning and Qualification Management
- Technical qualification at third level or equivalent in Engineering or science.
- Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects
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 Siobhan Cummins on 021 4777329 if you have anymore questions about this role!
