Validation Engineer

Priority may be given to the following designated employment equity groups: women, Indigenous peoples* (First Nations, Inuit and Métis) and persons with disabilities.
 
* The Employment Equity Act, which is under review, uses the terminology Aboriginal peoples and visible minorities.
 

City: Montréal 

Organizational Unit: Human Health Therapeutics 

Classification: RCO 

Tenure: Term 

Duration: 2 years

Language Requirements: Bilingual Imperative BBB/BBB 

Note: Due to the nature of the work and operational requirements, this position will require full-time physical presence at the NRC work location identified.

GREAT MINDS. ONE GOAL. CANADA'S SUCCESS. 
 
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 NRC, we know diversity enables excellence in research and innovation. We are committed to a diverse and representative workforce, an open and inclusive work environment, and contributing to a more inclusive Canadian innovation system. 
 
NRC welcomes all qualified applicants and encourages candidates to self-declare as members of the following designated employment equity groups: women, visible minorities, aboriginal peoples and persons with disabilities.
 
Please advise of any accommodation measures required to enable you to be assessed in a fair and equitable manner. They are available to all candidates for further assessment. Related information received will be addressed confidentially.

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 Validation Engineer for the Clinical Trial Material Facility (CTMF) at the Human Health Therapeutics (HHT) Research Center.  The candidate would be someone who shares our core values of integrity, excellence, respect and creativity.

The NRC is building a new permanent, GMP-compliant clinical trial material facility at its Royalmount Avenue site in Montréal. 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.

The Validation Engineer is required to function as subject-matter expert and provide expertise when advising the Validation Lead or when resolving issues related to the assessment of equipment, identifying and independently resolving issues.  The candidate determines the content for validation/qualification SOPs, which must support GMP standards. Judgement and initiative are required when developing reports to support the CTMF equipment and systems.  The candidate makes independent decisions related to the generation of quality data and effective analysis of data sets, which are critical to the operations. The expert advice and information provided by the Validation Engineer will effectively guide the decisions of projects.

The primary responsibilities of the Validation Engineer are to conduct engineering analysis in order to write, review and execute validation / qualification documents, write and review validation/qualification SOPs and attending FAT / SAT, execute validation and qualification protocols and manage, evaluate and process engineering studies.

That’s not all! You will also:

• Analyze and interpret test data and engineering data, in support of the Validation Lead
• Create flow diagrams and perform statistical analysis for process and PQ results
• Coordinate validation activities with internal departments as well as with subcontractors and external clients
• Participate in the resolution of deviations and Investigations
• Participate and support production departments during the execution of Engineering / Technical / Scale up Projects
• Responsible for ensuring the compliance of an equipment with its specifications.

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:

Bachelor's degree in Chemical, Mechanical, Industrial Engineering or related field.

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

• Significant experience in validation in the pharmaceutical/biopharmaceutical industry
• Experience in temperature mapping
• Experience in QMS, EMS, WMS and IT infrastructure validation
• Experience in qualification of aseptic production areas, utilities (HVAC, PW, WFI), and process equipment (incubators, bioreactors, Purification and filtration systems, including single-use equipment), temperature-controlled enclosures and storage
• Experience working in a biologic facility.

Reliability Status

Bilingual Imperative BBB/BBB 

Information on language requirements and self-assessment tests

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

• Solid knowledge of GMP/GLP and guidelines and regulations of the pharmaceutical/
• Knowledge of IQ, OQ, PQ
• Knowledge of cleaning validation principles
• Ability to manage multiple projects in a dynamic environment
• Solid understanding of validation requirements
• Superior writing skills as well strong accuracy and attention to detail
• Excellent interpersonal skills, communication and organizational skills.

• Management services - Communication (Level 2)
• Management services - Conceptual and analytical ability (Level 3)
• Management services - Teamwork (Level 2)
• Management services - Initiative (Level 2)
• Management services - Results orientation (Level 2)

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

View all competency profiles

Relocation assistance will be determined in accordance with the NRC's directives.

This position is classified as a Research Council Officer (RCO), a group that is unique to the NRC. Candidates are remunerated based on their expertise, outcomes and impacts of their previous work experience relative to the requirements of the level. The salary scale for this group is vast, from $57,220 to $161,754 per annum, which permits for employees of all levels from new graduates to world renowned experts to be fairly compensated for their contributions.

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, pension and insurance plans, vacation and other leave entitlements.

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• A pre-qualified list may be established for similar positions for a one-year period.
• NRC employees enjoy a wide range of benefits including comprehensive health and dental plans, pension and insurance plans, vacation and other leave entitlements.
• 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.

Please direct your questions, with the requisition number (18344) to:

E-mail: [email protected]

Telephone : 343-548-5849 

Closing Date: 17 February 2023 - 23:59 Eastern Time 

For more information on career tools and other resources, check out Career tools and resources

*If you are currently a term or continuing employee at NRC, please apply through the SuccessFactors Careers module from your NRC computer.