Validation Specialist

1 week ago

Montréal, Canada National Research Council Canada Full time

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

The new Biologics Manufacturing Centre (BMC), at the NRC, will improve the health of and make biomedical innovations more accessible to all Canadians by providing access to additional domestic production capacity for vaccines and biologic products in times of national and global emergencies and for unmet needs. The BMC will be certified as Good Manufacturing Practices (GMP) compliant, will have full end-to-end production capability for mammalian cell-based biologics. This includes a production capacity of approximately 4,000 litres per month, upstream and downstream processing, a quality control lab, filling and secondary packaging, and related logistics management for 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. Come and take part in the establishment of the facility and participate in obtaining a drug establishment license from Health Canada. NRC's intention is to transition the site to a different business model over the next few years so the status of positions will be re-evaluated regularly.

The Validation Specialist is responsible for the validation life cycle of equipment and systems, cleaning and sterilization methods and manufacturing processes. 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-conformances and ensures their resolution. He or she writes the required reports and summaries after execution. He or she then ensures that the validated state is maintained by evaluating changes and performing periodic re-qualifications.

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

**Screening Criteria**:
**Education**:
Bachelor's degree in science or engineering related to the position requirements.

Studies in microbiology would be an asset.

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 the field of validation in a regulated environment within the pharmaceutical or biotechnology industry (GMP).
- Experience in validation of cleaning and sterilization methods as well as validation of manufacturing processes, including media fill.
- Experience in qualification of aseptic production areas, utilities (clean is an asset), equipment (bioreactor, filtration, filling and secondary packaging, including single-use equipment), temperature controlled enclosures and warehouses.
- Experience in temperature mapping.

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

**Condition of Employment**:
Secret (II)

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**:
Bilingual Imperative BBB/BBB

Information on language requirements and self-assessment tests

**Assessment Criteria**:
**Technical Competencies**:

- Knowledge of cleaning, decontamination and sterilization.
- Knowledge of biomanufacturing processes and aseptic filling processes.
- Ability to read and interpret technical plans and drawings.
- Knowledge of mechanics, hydraulics, pneumatics and automation.
- Knowledge of investigation, deviation, change control and CAPA processes.

**Behavioural Competencies**:

- Technology support - Client focus (Level 2)
- Technology support - Teamwork (Level 2)
- Technology support - Initiative (Level 2)
- Technology support - Conceptual and analytical ability (Level 2)

**Competency Profile(s)**:
**Relocation**:
Relocation assistance will be determined in accordance with the NRC's directives.

**Compensation**:
From $73,744 to $94,839 per annum.

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

NRC employees e

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