Biopharmaceutical – C&Q Manager

5 days ago Be among the first 25 applicants

This range is provided by MMR Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$90,000.00/yr - $/yr

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services.

MMR Consulting has offices throughout North America and Asia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning and qualification of equipment, systems and facilities. The work will require working out of the client’s facilities in San Francisco Bay Area, California.

This role is for a Bioprocess C&Q Manager to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries.

• Provide technical guidance into the commissioning, qualification and start‑up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, buffers, media, chrom, TFF, washers & autoclaves, etc.
• Lead the development of key qualification deliverables during the project lifecycle to ensure the project is well defined, and the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle such as VPP, risk assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and that all specifications are met.
• Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities and facilities is an asset. Thermal validation experience is an asset.
• Coordinate meetings with cross‑functional departments, to drive project progress, facilitate decisions and provide updates.
• Engage other departments, as required, for design reviews and decisions.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning/validation phases.
• Client‑management: maintain key client relationships in support of business development and pursuit of new work, project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to sales as required for proposals/opportunities), presenting at industry conferences/publishing papers, etc.
• Visit construction and installation sites following all site safety requirements.
• Other duties as assigned by client and/or MMR, based on workload and project requirements.

• Excellent written and spoken English is required including the preparation of technical documents in English.
• 8+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Knowledge of requirements for a cGMP operation, including SOPs, change controls and validation.
• Experience with developing and executing validation projects. Risk‑based commissioning & qualification approaches, such as ASTM E‑2500 or ISPE ICQ, are considered an asset, but not required.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required.
• Experience with commissioning & qualification of process control systems (e.g. PCS, SCADA, historians) and building automation systems (e.g. Siemens Insight/Desigo, JCI Metasys) are considered an asset, but not required.
• Experience with qualification or validation of clean utilities, ISO clean rooms and thermal validation is considered an asset.
• Experience with preparation and execution of…