Senior Validation Engineer

Overview:

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