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IT Technical Lead, GMP Biologics

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: CS-3 

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 the NRC, we know that diversity enables excellence in research and innovation. We are committed to a diverse and representative workforce, a safe and respectful work environment, and contributing 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. 

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 an IT Technical Lead, GMP Biologics to support our new Clinical trial material facility with Human Health Therapeutics Research Centre . The selected candidate would be someone who shares our core values of Integrity, Excellence, Respect and Creativity.

 

The IT technical Lead (IT) is the expert on the Facility, laboratory and warehouse computer systems and infrastructure. The incumbent is independently responsible for regulatory compliance of IT operations, including IT validation. He or she is also responsible for the IT GMP components involved in the site, manage resources to align with priorities and deadlines; maximize productivity and maintain a high level of commitment; resolve issues and challenges; foster teamwork and communication.


Part of your challenge will include :

 

  • Responsible for ensuring compliance with applicable regulations (GxP, for example), making recommendations to comply with new regulations in this area and validating IT infrastructure and computer systems;
  • Responsible for plant IT GMP data protection; responsible for conducting risk analysis and identifying areas for improvement;
  • Sets annual budget requirements for operation and maintenance of the GMP infrastructure and GMP IT systems and manages the allocated budget to ensure planned deliverables and outcomes are achieved; makes recommendations for maintaining, upgrading and replacing IT assets;
  • Develops, implements and manages IT infrastructure and systems management processes and programs; ensures compliance with current pharmaceutical standards; develops and implements robust and effective procedures, tools, KPIs and processes that reflect the technical requirements of the plant;
  • Participates in the development, writing, implementation and compliance monitoring of standard operating procedures (SOP);
  • In the event of GMP-related incidents, informs the relevant departments and ensures that non-conformances are documented and investigated and that effective CAPAs are in place to prevent reoccurrence;
  • Responsible for the lifecycle of the IT infrastructure and systems related to GMP: URS (establishing requirements), design review, procurement, implementation and commissioning (including validation), change management (upgrades), maintenance and, lastly, phase-out.

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 of Sciences or equivalent discipline.

 

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

Experience

  • Extensive experience in an similar IT position in the pharmaceutical or biotechnology industry;
  • Extensive working experience of management and calibration management software QMS and EMS;
  • Extensive experience in Audit; 
  • Extensive experience in the configuration, operation, maintenance and monitoring of networking equipment, servers and storage of various brands;
  • Extensive experience with backup software; and
  • Experience with Historian, LIMS and CMMS/WMS is of added value.

 

Note: An extensive experience means at least 8 years.

Condition of Employment

Reliability Status

 

All employees of the National Research Council are required to be fully vaccinated against COVID-19 and attest to their vaccination status unless accommodated based on a medical contraindication, religion, or another prohibited ground of discrimination as defined under the Canadian Human Rights Act.

Language Requirements

Assessment Criteria

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

Technical Competencies

  • Working knowledge of investigation processes, deviation, control change and CAPA;
  • Working knowledge of management and calibration management software QMS and EMS;
  • Working knowledge of GMP IT environment; and
  • Working knowledge of GMP It infrastructure and Computerized systems malfunctions.

Behavioural Competencies

  • Technology support - Communication (Level 2)
  • Technology support - Conceptual and analytical ability (Level 3)
  • Technology support - Client focus (Level 3)
  • Technology support - Results orientation (Level 3)
  • Technology support - Teamwork (Level 2)

Competency Profile(s)

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

 

View all competency profiles

Relocation

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

Compensation

From $89,548 to $112,660 per annum.  In addition, the incumbent will receive the Bilingualism Bonus of $800 per year.  An incumbent occupying a position within the CS Group is currently entitled to receive a terminable allowance of $212 per month.

 

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

  • On October 6, 2021, the Government of Canada announced the launch of a mandatory vaccination policy across the federal public service. The Policy on COVID-19 Vaccination for the National Research Council requires you to be fully vaccinated against COVID-19, and that you attest to your vaccination status prior to the date of your appointment unless accommodated based on a medical contraindication, religion, or another prohibited ground of discrimination as defined under the Canadian Human Rights Act. You can find more specific information on the collection and use of your personal information when you submit your attestation.
  • A pre-qualified list may be established for similar positions for a one year period.
  • Overtime may sometimes be required.
  • 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 (17275) to:

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

Telephone: 343-548-5849 

Closing Date: 30 May 2022 - 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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