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Validation Specialist, IT Systems

City: Montréal

Organizational Unit: Biologics Manufacturing Centre 

Classification: TO-4 

Tenure: Term 

Duration: Until 31 March 2023 

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 Specialist, IT Systems to support our Biologics Manufacturing Centre. The selected candidate would be someone who shares our core values of Integrity, Excellence, Respect and Creativity. 

 

The new Biologics Manufacturing Centre (BMC), currently under construction by the NRC, will help to accelerate Canada’s capacity to produce, access and supply vaccines and other biologics. Certified as Good Manufacturing Practices (GMP) compliant, the facility will have full end-to-end production capability for mammalian cell-based biologics. This includes a production capacity of approximately 4000 litres per month, upstream and downstream processing, a fill and finish system, a quality control lab, secondary packaging, and related logistics management of final products.  In the short-term, the BMC’s top priority and focus is to help secure the production of a COVID-19 vaccine for Canadians as quickly as possible, once one is approved by Health Canada. In the longer term, the BMC’s focus will be on providing innovative solutions for the domestic production and supply of novel biologics for the future, while providing Canada with access to a facility that is ready to respond to emergencies, such as a pandemic.

 

The validation specialist is responsible for the validation life cycle specific to the computerized systems.  He or she participates in the definition of requirements, defines the validation strategy, writes the appropriate protocols and plans, directs and participates in their execution.  He or she documents non-conformities and ensures their resolution.  He or she writes the reports and summaries required after execution.  He or she then ensures that the validated state is maintained by evaluating changes made and proceeding to periodic requalifications.

 

The Validation Specialist is also responsible for coordinating with the various departments and external suppliers involved in validation activities and ensuring that the required deliverables are in place at the right time.

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 sciences or engineering relevant to the position.

 

An equivalent combination of education and experience may be considered.

 

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

Experience

  • Significant experience in validation and engineering in a regulated environment within the pharmaceutical or biotechnology industry (GMP).
  • Experience in life cycle management and validation of computerized systems.
  • Experience in validation of QMS, EMS, ERP, LIMS and IT infrastructure.

 

Note: Significant experience is defined as 5 to 8 years of experience.

Condition of Employment

Secret (II)

Language requirements

Assessment Criteria

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

Technical Competencies

  • In-depth knowledge of current regulations (PICS, ISPE Guideline, Health Canada guides).
  • Technical knowledge of computerized systems (design and implementation).
  • Ability to create protocols, reports, user requirements specifications, procedures and similar technical documents.

Behavioural Competencies

  • Technology support - Conceptual and analytical ability (Level 2)
  • Technology support - Initiative (Level 2)
  • Technology support - Results orientation (Level 2)
  • Technology support - Teamwork (Level 2)

Competency Profile(s)

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

 

View all competency profiles

Relocation

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

Salary Range

From $72,654 to $93,437 per annum. 

 

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

Notes

  • Overtime may be required from time to time.
  • 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 (11406) to:

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

Telephone: 613-949-7685 

Closing Date: 22 January 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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