Facility and Engineering Manager

Your Challenge

Great Minds. One Goal. Canada's Success.

Help bring research to life and drive your career forward with the National Research Council of Canada (NRC), Canada's largest research and technology organization.

We are looking for a Facility and Engineering Manager to support the Clinical Trial Material Facility at Human Health Therapeutics. The selected candidate would be someone who shares our core values of Integrity, Excellence, Respect and Creativity.

The NRC is building a new permanent, Good Manufacturing Practices (GMP)-compliant Clinical Trial Material Facility at its Royalmount Avenue site in Montreal. When complete, this facility will be used to manufacture vaccine and other biologic materials for clinical trials, to support vaccine development at the clinical trial stage.

As a member of the multidisciplinary project teams, the validation specialist actively participates in all stages of the validation lifecycle for equipment, systems, and processes in compliance with applicable regulations, policies and procedures.

Responsibilities are including:

• Prepare, revise, and maintain the master validation plan
• Participate in factory acceptance testing (FAT) and site acceptance testing (SAT), if applicable.
• Perform qualification and validation of new and existing equipment, utilities, facility and processes with the focus on (GMP) compliance in collaboration with the quality assurance and other team members.
• Proactively coordinate with Operations, Quality and other departments to ensure validation studies are conducted in a timely manner.
• Review and approve deviation/non-conformance/change control/Corrective and Preventive Actions (CAPA) reports and records from validation/qualification perspective
• Review qualification and validation documentation of equipment, utilities, facility and processes with the focus on GMP compliance
• Maintain the equipment validation program and review all validation documents in the validation lifecycle to ensure compliance
• Participate in Change Control evaluations of validated systems, assess impact and determine re-validation needs per proposed changes
• Review and approve calibration Standard Operating Procedures (SOP) and work instructions.
• Review and approved preventive maintenance SOPs and work instruction.
• Review and approve preventive maintenance and calibration work orders.
• Review and approve engineering drawing from vendors.
• Manage the maintenance and engineering expense as per the establish budget.
• Review and approve Commissioning and Engineering study.
• Manage maintenance spare parts and maintenance material.

Screening Criteria

Applicants must demonstrate within the content of their application that they meet the following screening criteria in order to be given further consideration as candidates:

Education

Bachelor's Degree in Engineering (Chemical, Mechanical, Electrical, Industrial).

For information on certificates and diplomas issued abroad, please see Degree equivalency

Experience

• Extensive experience in biopharmaceutical / pharmaceutical/ biotechnology sector in validation or in a similar role reviewing validation documents (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ))
• Extensive experience in biopharmaceutical / pharmaceutical/ biotechnology sector in maintenance and engineering or in a similar role reviewing maintenance and engineering documents (User Requirements Specification (URS), Basis of Design (BOD), Functional Requirements Specification (FRS), Commissioning)
• Extensive experience in qualification of aseptic production areas, utilities (Heating, Ventilation and Air Conditioning (HVAC), Purified Water (PW), Water for Injection (WFI)), equipment (incubators, bioreactors, Purification and filtration systems, including single­ use equipment), temperature-controlled enclosures, storage, Environmental Monitoring System (EMS) and bio-decontamination system.
• Experience in Operational Management System (OMS), Building Management System (BMS), Warehouse Management System (WMS) and Information Technology (IT) infrastructure validation is considered an asset.
• Extensive experience in maintaining calibration and preventive maintenance program.
• Experience is automation process control in current Good Manufacturing Practice (cGMP) equipment.
• Significant supervisory experience 

Assets: 

• Experience in temperature mapping is considered an asset.
• Experience in using Trackwise Quality Management System (QMS)

Condition of Employment

 Secret (II)

Language Requirements

Bilingual Imperative BBB/BBB

Information on language requirements and self-assessment tests

Assessment Criteria

Candidates will be assessed on the basis of the following criteria:

Technical Competencies

• Strong multi-faceted technical background and understanding of validation frameworks across all operations functions
• Solid understanding of validation requirements
• Superior writing skills as well strong accuracy and attention to detail.
• Excellent interpersonal skills, communication and organizational skills.
• Strong judgment, decision making and trouble shooting skills.
• Strong knowledge of GMP
• Knowledge of IQ, OQ, PO
• Knowledge of cleaning validation principles is considered an asset.

Behavioural Competencies

Competency Profile(s)

For this position, the NRC will evaluate candidates using the following competency profile: Management Services;

View all competency profiles

Compensation

The intent of this hiring action is to staff this position at the RCO-3 level, which is a mid-career level position with a salary range of $114,753 to $133,853.. 

NOTE: Please note that the full RO/RCO salary scale has five levels. Salary determination will be based on a review of the candidate’s expertise, outcomes and impacts of their previous work experience relative to the requirements of the level.  As such, the initial salary could be within another level of the RO/RCO salary scale (i.e. above or below the intended level for this position).

In addition, the incumbent will receive the Bilingualism Bonus of $800 per year.

NRC employees enjoy a wide-range of competitive benefits including comprehensive health and dental plans, vacation, sick, and other leave entitlements, disability insurance and pension plans.

The NRC Advantage

The National Research Council of Canada (NRC) is the Government of Canada's largest research organization supporting industrial innovation, the advancement of knowledge and technology development. We collaborate with over 70 colleges, universities and hospitals annually, work with 800 companies on their projects, and provide advice or funding to over 8000 Small and Medium-sized Enterprises (SMEs) each year.

We bring together the brightest minds to deliver tangible impacts on the lives of Canadians and people around the world. And now, we want to partner with you.  Let your expertise and inspirations make an impact by joining the NRC.

At the NRC Employee wellness matters. We offer flexible work schedules as well as part-time work to help employees maintain work-life balance. We are one of the few federal organizations that close our offices during the December holiday season.  We offer professional learning and development opportunities such as conferences, workshops, and a suite of mentorship, award and recognition programs. Diversity enables creativity and innovation. Fostering a diverse, inclusive, welcoming and supportive workplace is important to us, and contributes to a more inclusive Canadian innovation system. We welcome all qualified applicants and encourage you to complete the employment equity self-declaration questions during the job application process. Please let us know of any accommodation measures required to help you to be assessed in a fair and equitable manner. Please note that the information you provide will be treated confidentially. 

Help us solve problems for Canada. Grow your career with us today!

Notes

• Relocation assistance will be determined in accordance with the NRC's directives.
• ​A pre-qualified list may be established for similar positions for a one year period.
• Preference will be given to Canadian Citizens and Permanent Residents of Canada. Please include citizenship information in your application.
• The incumbent must adhere to safe workplace practices at all times.
• We thank all those who apply, however only those selected for further consideration will be contacted.