Pharmaceutical – Senior CQV Lead

PHARMACETICAL – CQV Lead / CQV Manager – Large Expansion projects
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 in Canada, USA, and Australia.

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.

This role is for Senior CQV Lead role 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.

The work will require working out of the client’s facilities in San Diego, California.

The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

• Lead large CQV projects from inception through to full doc prep, execution and closure
• Setup the CQV Strategy and CQV plans for large expansion projects, including resources, org chart, deliverables, schedule
• Drive CQV projects through to completion
• Provide technical expertise in at least one workstream (Upstream, Downstream, Clean Utils, Utilities, Laboratories, Automation)
• Experience with ASTM E2500, and ISPE Integrated C&Q approaches
• Provide technical guidance in the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities.
• Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle.
• Able to perform field execution of qualification test cases and protocols.
• Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
• Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following – Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, into design reviews and decisions.
• Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification and validation phases.
• Visit construction and installation sites, wearing necessary safety PPE.
• You may be involved with other aspects such as 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.
• Lead/Mentor a team of validation engineers/specialists.
• Supervise contractors during critical testing of system and equipment.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

• 12+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for cGMP operations.
• Experience, with commissioning & qualification of equipment & facilities is required.
• Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is preferred.
• Experience with developing and executing validation…