Pharmaceutical - Cqv Manager
3 weeks ago
**Pharmaceutical - CQV Manager**
**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 has offices in Canada, USA, Australia, Singapore and India.
**Responsibilities**
- Directly manage / lead a team of CQV engineers / specialists.
- 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 quality and engineering specifications are met.
- Experience with C&Q of upstream or downstream bioprocess 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.
- Lead the development of validation strategies or deliverables such as protocols, reports, deviation resolution process and training during the project validation lifecycle.
- Able to perform field execution of validation test cases and protocols.
- Lead 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 such as DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and regulatory specifications are met.
- Provide technical guidance into the Process Validation (PV) and / or Cleaning Validation (CV) aspects of Manufacturing Science and Technical Operations (MSAT) in the pharmaceutical / biopharmaceutical cGMP manufacturing or R&D operations.
- Serve as Validation SME, coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates for execution of validation activities.
- Engage other departments, as required, in 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.
- Supervise contractors during critical testing of system and equipment.
- Other duties as assigned by client, and/or MMR, based on workload and project requirements.
- As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable
**Qualifications**
- Years of experience: 10+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 8 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 leading the development and execution of validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
- 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 required.
- Thermal validation experience is considered an asset.
- Experience with commissioning and qualification of process equipment for aseptic fill-finish and pharmaceutical API and OSD manufacturing processes as well as food/ FMCG manufacturing processes are considered an asset.
- Experience with qualification or validation of clean utilities and HVAC/ISO clean rooms.
- Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
- Possess knowledge of relevant regulatory requireme
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