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 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.

Requirements:

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