Overview:
Our client, a leading global biopharmaceutical organisation is seeking a Validation Engineer to join their team in Dublin. This is a fantastic opportunity for an experienced Validation Engineer to be responsible for executing and documenting validation activities for new and existing equipment and systems. This role ensures all processes are compliant with GMP and regulatory requirements.
This is a 12 month hourly rate contract position.
Key Responsibilities:
- Draft, execute, and approve CQV test documentation (e.g., FAT, SAT, PQ)
- Pre-Approve and Post-Approve validation protocols
- Input into site Validation Master Plans and Standard Operating Procedures (SOP's)
- Collate and Report on 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 / Experience:
- Degree in Science, Engineering, or related discipline
- 6+ years experience in Validation
- Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects
- Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry
- Experience of sterile / biotech equipment within the pharmaceutical industry is required
- Experience using Paperless Qualification Systems is preferred
- Knowledge of safety and GMP requirements
- Strong Communication skills
