Pharmaceutical - Commissioning & Qualifications (C&Q) Engineer / Specialist

Job Description

Job Description

Salary : 70,000$ -120,000$

Commissioning & Qualifications (C&Q) Engineer / Specialist

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMRs Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities. The work may require working out of clients facilities, which are typically in theGreater Toronto Area(within one hour driving distance of Toronto).

We are hiring at different levels (Senior / Intermediate / Junior) based on years of experience. Please refer to Position Level section.

Previous Pharmaceutical / Biotech experience is MANDATORY for this role.

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & 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
• 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 to ensure all quality and engineering specifications are met.
• Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, 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.
• 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 clients safety rules including mandatory vaccination policies for COVID-19, where applicable

Qualifications

Position Levels

8 Years

Salary range : 70,000$ -120,000$ based on experience.

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Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.