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Validation Lead, GMP Biologics

City: Montréal

Organizational Unit: Human Health Therapeutics 

Classification: RCO 

Tenure: Term 

Duration: 2 years 

Language Requirements: Bilingual Imperative BBB/BBB

The NRC Advantage

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.

Your Challenge

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 Lead 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, 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.

 

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 manufacturing Operations, Quality and other departments to ensure validation studies are conducted in a timely manner. 
  • Review and approve deviation/non-conformance/change control/CAPA (events) 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

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

Master’s Degree in Chemistry, Biochemistry, Microbiology, Engineering (Chemical, mechanical) or other related discipline.

 

A Bachelor’s degree combined with relevant experience may be considered.

 

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
  • Experience in qualification of aseptic production areas, utilities (HVAC, PW, WFI), equipment (incubators, bioreactors, Purification and filtration systems, including single-use equipment), temperature-controlled enclosures and storage. 
  • Experience in temperature mapping is considered an asset.
  • Experience in QMS, EMS, WMS and IT infrastructure validation is considered an asset.

Condition of Employment

 Reliability Status

Language Requirements

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, PQ
  • Knowledge of cleaning validation principles is considered an asset.

Behavioural Competencies

  • Management services - Communication (Level 3)
  • Management services - Conceptual and analytical ability (Level 2)
  • Management services - Organizational and environmental awareness (Level 3)
  • Management services - Results orientation (Level 3)

Competency Profile(s)

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

 

View all competency profiles

Relocation

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

Compensation

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.

Notes

  • ​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.

 

 

Please direct your questions, with the requisition number (13101) to:

E-mail: NRC.NRCHiring-EmbaucheCNRC.CNRC@nrc-cnrc.gc.ca

Telephone: 613-949-7685 

Closing Date: 26 October 2021 - 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.

 

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