Job Purpose
The Commissioning & Validation Engineer provides specialized scientific and technical support for the validation, revalidation, and requalification of laboratory equipment and computerized systems. These activities are performed in strict adherence to current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and regulatory guidelines, with a continuous focus on enhancing quality and operational efficiency.
Key Responsibilities
Validation & Documentation
- Protocol Development & Execution: Develop validation protocols based on comprehensive Validation Plans. Execute validations, revalidations, and requalifications for lab equipment, including computerized systems, in compliance with internal and external standards.
- Reporting & Documentation: Author validation summary reports, ensuring accuracy, technical soundness, and adherence to all regulatory requirements. Review and approve validation documentation to maintain compliance.
- Maintenance & Requalification: Regularly perform validation maintenance reviews and requalification of lab equipment to ensure sustained compliance with GMP standards.
- Equipment Decommissioning: Support the decommissioning process for lab equipment, ensuring proper documentation and compliance throughout.
Collaboration & Investigation
- Cross-Functional Coordination: Work cross-functionally with relevant stakeholders to ensure timely and accurate execution of validation projects.
- Discrepancy Management: Investigate and resolve any discrepancies encountered during validation and qualification processes.
- Vendor Protocol Review: Review and provide input on vendor validation protocols and reports, including managing discrepancy investigations.
Quality Assurance
- Lifecycle Documentation: Participate in multi-disciplinary project teams for writing, executing, and reviewing validation lifecycle documentation, ensuring it meets all scientific and safety standards.
- Protocol Compliance: Ensure validation protocols are executed according to study plans and regulatory expectations.
Requirements
- Experience: Minimum of 3 years in pharmaceutical manufacturing, with a strong foundation in cGMPs and validation practices.
- Regulatory Knowledge: Familiarity with FDA, EMEA, GAMP, ICHQ7, and other relevant regulatory guidelines.
- Lab Equipment Qualification (LEQ): Extensive hands-on experience with lab equipment validation and qualification, preferably in the biotech sector.
- GMP Expertise: Experience in a GMP-compliant environment with thorough knowledge of GMP regulations.
- Validation & QA: Proven experience in validation procedures and quality assurance,with a focus on maintaining high scientific quality in all validation activities.
- Project Management & Communication: Strong project management, multitasking, and independent working skills. Excellent communication and teamwork abilities, with an emphasis on safety, quality, and meeting deadlines.
