About the Role
We are looking for an experienced Validation Engineer to support the Commissioning, Qualification, and Validation (CQV) activities for an ongoing fill-finish expansion project.
This mid-level role will involve executing qualification protocols, supporting commissioning activities, and ensuring all systems (utility and process equipment) meet the required regulatory and operational standards.
Key Responsibilities
- Execution of Qualification Protocols: Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for utility systems (e.g., HVAC, WFI, purified water, compressed air) and process equipment (e.g., filling lines, capping systems, packaging equipment).
- Commissioning Support: Assist in commissioning activities for systems and equipment, ensuring adherence to specifications, regulations, and operational requirements.
- Documentation: Ensure that all validation documentation is accurate, complete, and in compliance with GMP and regulatory requirements.
Review and approve qualification reports, test results, and associated documentation.
- Deviation Management: Support the investigation and resolution of any deviations identified during the qualification process and ensure proper documentation of corrective actions.
- Cross-Functional Collaboration: Work closely with engineering, operations, and quality assurance teams to ensure a smooth validation process and meet project timelines.
- System Monitoring: Track progress and maintain a system to monitor and report validation status and compliance during the C&Q phase.
- Training and Support: Provide support and guidance to junior validation engineers and help with training on validation activities and protocols.
Key Requirements
- Education: Bachelor's degree in Engineering (Mechanical, Chemical, Biochemical, or related field).
- Experience: Minimum of 5 years of experience in validation, commissioning, and qualification within pharmaceutical or biotech environments.
- Technical Skills:
Strong hands-on experience with utility systems (WFI, HVAC, purified water, compressed air) and process equipment (filling, capping, and packaging systems).
Solid understanding and experience with IQ/OQ/PQ protocols.
Familiar with GMP and GxP regulations and their application to qualification activities.
- Attention to Detail: Ability to ensure the thorough execution of qualification protocols and proper documentation of deviations and corrective actions.
- Communication Skills: Good written and verbal communication skills to work with project teams and document validation results.