Validation Engineer

Responsibiltiies :

• Develop comprehensive protocols for the qualification / requalification of new and existing QM micro and QC analytical equipment.
• Develop comprehensive protocols for the qualification of required clean utilities to service new QC Micro and QC analytical laboratory.
• Develop comprehensive protocols for the qualification of new EMS monitoring points for CTUs and equipment alarming.
• Ensure protocols adhere to in CFR Part and EU Annex and are aligned with quality policies, procedures, and the Validation Master Plan (VMP) of the Gaithersburg site.
• Implement and execute protocols / test scripts for the qualification of equipment, including but not limited to temperature mapping and installation, operational, and performance qualification verifications.
• Coordinate with relevant BNT stakeholders CQV manager and BNT CQV lead to execute protocols / test scripts efficiently.
• Document qualification results and provide recommendations for any necessary adjustments or corrective actions.
• Conduct thorough reviews of executed protocols to ensure completeness and accuracy.
• Address and generate any discrepancies, exceptional conditions or deviations identified during the review / execution process.

Requirements :

• Minimum of - years of hands-on experience in equipment qualification, including protocol development, execution, and review.
• Familiarity with equipment qualification processes (IQ, OP, and PQ), including temperature mapping using Kaye AVS and Kaye Val probes.
• Proven record of delivering projects on time and within budget while adhering to regulatory requirements.
• Demonstrated understanding of regulatory requirements relevant to equipment qualification in the biotech or pharmaceutical industry, including cGMP, GLP, and GAMP guidelines.
• Minimum of a bachelor's degree in a scientific field such as Biology, Chemistry, Biochemistry, Engineering, or related discipline
30+ days ago