Commissioning & Qualification Lead / Manager
1 week ago
**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**
- 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.
- Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
- Lead C&Q of upstream or downstream bioprocess systems.
- Lead C&Q of process equipment for other processes such as aseptic fill-finish and pharmaceutical API and OSD processes, as well as utilities and facilities.
- 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.
- Business Development associated with generation of new client accounts and 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.
**Qualifications**
- Excellent written and spoken English is required including the preparation of technical documents in English.
- 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.
- Previous experience in business development or sales in the pharmaceutical / biotech industry in Singapore will be an asset.
- 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, 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 & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) is considered an asset.
- Experience with commissioning and qualification of process equipment for aseptic fill-finish and pharmaceutical API and OSD manufacturing processes is 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.
- Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not required.
- Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
- Ability to lift 50 lbs.
- Possess mentorship skills, to coach and develop junior and intermediate employees.
- Engineering or Science degree, preferably in Mechanical, Chemical, Biochemical, or a related discipline.
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills.
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