Bio-Process Associate
3 days ago
Description:
PE Global is currently recruiting for a Senior Validation Engineer on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.
Overview:
Validation Engineer responsible for ensuring that the Validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and Quality Requirements.
Responsibilities:
- Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Installation 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).
- Collate and Report on relevant validation data/metrics.
- 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).
Education and Experience:
- 6+ years experience in Engineering or Validation.
- Technical qualification at third level or equivalent in Engineering.
- Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects.
- Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
- Knowledge of safety and GMP requirements.
- Demonstrated strong Communication skills.
- Experience using Paperless Qualification Systems is preferred.
- Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry.
Interested candidates should submit an updated CV.
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