Senior Validation Engineer (BBBH28102) Dublin South, Republic of Ireland
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!
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