Biopharmaceutical SR. Commissioning & Qualification Specialist

Overview

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 Validation.

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 specialists involved in project management, commissioning and qualification of equipment, systems and facilities.

This role is for Sr. CQV Specialist and will require work on the validation of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor intermediate and junior specialists.

The work will require working out of client facilities, typically in the Greater Raleigh and surrounding areas in North Carolina.

• Provide technical guidance into the commissioning, qualification and start-up of various pharmaceutical/biopharmaceutical cGMP process equipment, utilities and 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.
• 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 that all specifications are met.
• Possess knowledge of relevant regulatory requirements and industry best practices on process equipment, clean utilities, automation systems, laboratory equipment, and building facilities.
• Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and 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.
• Involve with client-management, project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development, and presenting at industry conferences or publishing papers as required.
• Supervise contractors during critical testing of systems and equipment.
• Other duties as assigned by client and/or MMR based on workload and project requirements.
• Lead/mentor a team of validation specialists.

• 12+ years of experience in commissioning, qualification and validation of various systems within the pharmaceutical/biotech industry.
• Experience with commissioning and qualification of equipment and facilities is required.
• Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, and computer systems validation is an asset but not required.
• Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ.
• Experience with commissioning and qualification of process control systems (e.g., PCS, SCADA, Historians) and building automation systems is considered an asset.
• Experience with commissioning and qualification of biotech process equipment (e.g., fermentation, bioreactors, downstream purification processes such as chromatography, TFF, UF, CIP systems, Buffer systems, Clean Utilities would be an asset).
• Experience with Qualification or Validation of clean utilities and ISO clean rooms.
• Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs.
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not…