Responsibilities:
Seeking proposals to support the relocation of QC microbiology and QC analytical equipment from current labs to a new facility.
This includes approximately 50 pieces of GMP equipment, primarily benchtop lab equipment like QC-M and QC-analytical instruments, which will require qualification or installation verification.
This includes various CTUs such as incubators, fridges, and refrigerators.
The successful proposal will involve ensuring that the equipment meets regulatory compliance through qualification and requalification.
We are seeking three full-time on-site resources with 2-3 years of equipment qualification experience, encompassing protocol generation, execution, and review.
The primary objective is to ensure a smooth transition while maintaining operational efficiency and compliance.
The qualifications will occur at the 930 Clopper Road facility.
"QC Micro " refers to quality control microbiology equipment.
"QC Analytical Equipment " refers to quality control analytical equipment.
"CTU refers to Controlled Temperature Units
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:
Fully executed protocols/test scripts with documented results using BNT templates for all QC-M, QC-Analytical and supporting systems for new BNT laboratory.
Required completed Validation Summary Reports for all equipment or systems as required and identified for new BNT QC laboratory.
The QC-Microbiology equipment move is expected to begin in early April 2024, followed by the QC-Analytical equipment move in May 2024.
It is anticipated that all equipment and system qualifications must be completed by July 31, 2024. Resource details will need to be provided two weeks in advance of the expected start date to ensure all necessary internal control requirements are met before granting site access.
Demonstrated understanding of regulatory requirements relevant to equipment qualification in the biotech or pharmaceutical industry, including cGMP, GLP, and GAMP guidelines.
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.
Excellent written and verbal communication skills to effectively interact with stakeholders and document qualification procedures and results.
Minimum of a bachelor's degree in a scientific field such as Biology, Chemistry, Biochemistry, Engineering, or related discipline.
