Previous Pharmaceutical/Biotech experience is mandatory for this role.

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

MMR Consulting has offices in Canada, USA, and Australia.

This role is based out of the Greater Toronto, ON area. Some travel within the GTA is expected.

This role is for an Automation Validation Engineer role to work on the commissioning, qualification, startup of Automation systems in the pharma/biotech industry, such as Process Controls and Building Automation. The ideal candidate should possess leadership skills to lead/mentor junior engineers.

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.
• Experience with C&Q of either Process Controls (i.e. DCS, PLCs, SCADA/Historians) or Building Automation Systems (i.e. Siemens Insight / Desigo, JCI Metasys) is required.
• Experience with C&Q of upstream or downstream bioprocess systems, or other process equipment, utilities, facilities is considered a strong asset.
• 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.
• 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.
• 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
• Visit construction and installation sites.
• Supervise contractors during critical testing of system 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: 6+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 3+ years should include direct C&Q experience with either process automation or building automation systems in the pharma/biotech industry.
• 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.
• Knowledge of GAMP and Data Integrity requirements.
• Knowledge of the V-Model for Computer System Validation is required.
• Knowledge of ISA-88 and ISA-95 Standards is considered an asset.
• Experience with commissioning & qualification of either process control systems (i.e. PCS, SCADA, Historians) or building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) is considered an asset.
• 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 considered an asset.
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
• Experience with preparation and execution of URSs, DQs, 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.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Engineering or Science degree, preferably in Mechanical, Electrical, Electromechanical, Chemical, Biochemical or a related discipline.
• Travel may be required on occasion.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills
• Ability to lift 50 lbs.

Compensation range: 80,000$- 110,000$ per year based on industry experience.

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.