Pharmaceutical Commissioning & Qualifications (C&Q) Engineer Specialist

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

• 5 8 years of experience in commissioning qualification or validation of various systems within the pharmaceutical/biotech industry.
• Previous experience in the pharmaceutical / biotech industry with knowledge of requirements for cGMP operations.
• Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches such as ASTM E-2500 or ISPE ICQ is considered an asset but not required.
• Experience with commissioning & qualification of process control systems (i.e. PCS SCADA Historians) and building automation systems are considered an asset.
• Experience with commissioning and qualification of biotech process equipment such as some but not all of the following: fermentation bioreactors downstream purification processes (chromatography TFF UF) would be an asset.
• Experience with Qualification or Validation of clean utilities and ISO clean rooms.
• Experience with preparation and execution of URSs DQs RTMs Risk Assessments CPPs VPPs FATs SATs IOQs
• 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.
• Possess mentorship skills to coach and develop junior and intermediate employees.
• Engineering degree preferably in Mechanical Electrical or Chemical.
• Travel may be required on occasion.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills

Position Levels

• Senior > 8 Years
• Intermediate 5 7 Years

Salary range: 70000$ -120000$ based on experience.

Send your resume to:

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.

Required Experience:

Manager