Pharmaceutical Commissioning
5 days ago
MMR Consulting is a leading engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. With offices in Canada, USA, and Australia, we provide a wide range of services including Engineering, Project Management, Validation, and other Consulting services.
This role offers an outstanding opportunity to join our growing team as a Commissioning & Qualification (C&Q) Validation Manager. You will work with a group of engineers and specialists involved in project management, commissioning, and qualification of equipment, systems, and facilities. This role is based out of the Greater Toronto, ON area, with some travel expected.
Job SummaryWe are seeking an experienced Commissioning & Qualification (C&Q) Validation Manager to lead our team in the commissioning, qualification, and startup of various pharmaceutical/biotech systems. The ideal candidate will possess leadership skills to mentor junior engineers and have experience with commissioning & qualification of equipment & facilities, process control systems, building automation systems, and clean utilities.
Responsibilities- Directly manage/lead a team of CQV engineers/specialists
- Provide technical guidance on commissioning, qualification, and start-up of various pharmaceutical/biotech cGMP process equipment, utilities, and facilities
- Lead the development 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 ensure all quality and engineering 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
- 8+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry
- Some previous leadership experience required
- 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 an asset but not required
- Previous experience in the pharmaceutical/biotech industry, with knowledge of requirements for cGMP operations
- Engineering degree, preferably in Mechanical, Electrical, or Chemical
The estimated salary for this role is $100,000 per year, plus benefits. The base salary offered will be determined by the successful candidate's relevant experience, skills, and competencies, while ensuring internal equity is maintained. Experienced candidates may be offered a higher salary range based on their level of expertise and qualifications.
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Greater Toronto Area, Canada MMR Consulting Full timePharmaceutical - Commissioning & Qualification (C&Q) Validation 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, Validation and other Consulting services....
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Greater Toronto Area, Canada MMR Consulting Full timePharmaceutical - Commissioning & Qualification (C&Q) Validation ManagerPrevious 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, Validation and other Consulting services. MMR...
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Greater Toronto Area, Canada MMR Consulting Full timePharmaceutical - Commissioning & Qualification (C&Q) Validation ManagerPrevious 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, Validation and other Consulting services. MMR...
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