LSC have a great contract opportunity for a Senior Validation Engineer to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects.
- Experience filling or vial line.
- Experience with AVS (Airflow Visualization) Studies (advantageous).
- Experience of aseptic processing (advantageous).
- Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IV's), Functional Testing (FT's), Site Acceptance Testing (SAT) and Performance Qualifications (PQ's) associated with a Syringe Filling Line.
- Pre-Approve and Post-Approve validation protocols.
- Input into site Validation Master Plans and Standard Operating Procedures (SOP's)
- Assist in exceptions and deviation resolution and root cause analysis.
- Reviews Validation planning documents detailing overall strategy for the project.
- Reviews and Approves Qualification summary reports (QSR)
- Generates Validation Summary reports.
- Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 6+ years experience in Engineering or Commissioning and Qualification Management
- Technical qualification at third level or equivalent in Engineering.
- Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred.
- Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
- Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry
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 at +353 214777329 if you have any more questions about this opportunity!
