Biopharmaceutical – C&Q Manager

Previous Pharmaceutical/Biotech experience is mandatory for this role.

The work will require working out of client’s facilities, which are in Raleigh, NC, US . Relocation and/or Travel Expense package to Raleigh, NC, US is available for this role.

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

MMR Consulting has offices in Canada, USA, and Australia Asia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start‑up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

This role is for C&Q Manager will require to work on the commissioning, qualification & validation of Upstream Bioprocess Equipment (Bioreactors, Fermantation, Centrifugation, etc…) in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

The work will require working out of client’s facilities, which are in Raleigh, NC, US.

• Provide technical guidance into the commissioning, qualification and start‑up of various equipment and facilities used in life science manufacturing, such as Upstream Bioprocess Equipment (Bioreactors, Fermantation, Centrifugation, etc…) bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, etc.
• Lead the development of key qualification deliverables during the project lifecycle to ensure 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 to ensure all specifications are met.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q of Upstream Bioprocess Equipment systems is required.
• Experience with C&Q of other process equipment, utilities, facilities is an asset.
• Thermal Validation experience is an asset.
• Coordinate meetings with cross‑functional departments, to drive project progress, facilitate decisions, 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 the 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
• Years of experience: 5 + years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Knowledge of requirements for a cGMP operations, including SOPs, Change…