Validation Engineer
Katalyst Healthcares & Life Sciences
- Gaithersburg, MD
- Permanent
- Full-time
- 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 21CFR Part 211 and EU Annex 1 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.
- Minimum of 2-3 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