BIOPHARMACEUTICAL – C&Q Manager

About the role

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries, offering services in Engineering, Automation, Project Management, and ValidationCQV, with offices in Canada, the USA, and AustraliaAsia. This is an outstanding opportunity to join a growing team where you will work with engineers on the design, commissioning & qualification, start‑up, and project management of various processes, systems, and facilities. The role is for a C&Q Manager focusing on the commissioning, qualification, and validation of Upstream Bioprocess Equipment (bioreactors, fermentation, centrifugation, etc.) and other process equipment in the biopharma and pharma/biotech sectors. Previous pharmaceutical/biotech experience is mandatory, and the work will be performed at client facilities in Raleigh, NC, US. A relocation and/or travel expense package to Raleigh, NC, US is available. The ideal candidate should possess leadership skills to lead teams of intermediate and junior engineers.

Responsibilities

• Provide technical guidance into the commissioning, qualification, and start‑up of life‑science manufacturing equipment and facilities, including upstream bioprocess equipment (bioreactors, fermentation, centrifugation), bioreactors, tanks, CIP, buffers, media, chromatography, TFF, washers, autoclaves, etc.
• Lead the development of key qualification deliverables throughout the project lifecycle to ensure the project is well defined and the test plan is applicable and relevant.
• Lead qualification processes (VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ, PQ) as appropriate to ensure timely completion and that all specifications are met.
• Prepare protocols, execute protocols, summarize data, resolve deviations, and prepare final reports.
• 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 occasionally for client meetings, equipment fabrication vendor visits, or Factory Acceptance Testing (FATs).
• Provide occasional support over shutdowns or extended hours during installation, commissioning, and validation phases.
• Perform client‑management: maintain key client relationships to support business development, coordinate project scheduling/budgeting, align client and MMR resources, and support business development with technical input for proposals/opportunities.
• Present at industry conferences and publish papers as appropriate.
• Visit construction and installation sites while observing all site safety requirements.
• Carry out other duties as assigned by the client or MMR based on workload and project requirements.

Qualifications

• Excellent written and spoken English, including the ability to prepare technical documents in English.
• Minimum 5+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry.
• Knowledge of cGMP requirements, including SOPs, change controls, and validation.
• Experience developing and executing validation projects.
• Experience with commissioning and qualification of biotech process equipment and systems, including upstream bioprocess equipment (bioreactors, fermentation, centrifugation) and downstream purification processes (chromatography, TFF, UF).
• Experience with risk‑based commissioning & qualification approaches (e.g., ASTM E‑2500, ISPE ICQ) is an asset but not required.
• Experience with commissioning & qualification of process control systems (PCS, SCADA, Historians) and building automation systems (Siem