Biopharmaceutical Commissioning & Qualification Specialist

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV.

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. The work will require working out of the client’s facilities.

This role is for C&Q Specialist 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 ideal candidate should possess leadership skills to lead/mentor intermediate/junior specialists.

The work will require working out of the client’s facilities in Greenville, North Carolina.

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
• 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, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all specifications are met.
• Experience with C&Q parts washer and autoclave 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.
• Supervise contractors during critical testing of systems and equipment.
• 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: 8+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 6 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is an asset.
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset.
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
• Experience with preparation and execution of URS’s, DQ’s,…