Validation Specialist

3 months ago

Montréal, Canada Centre de production de produits biologiques Inc Full time

The Biologics Manufacturing Center (BMC) inc. is a new bio-manufacturing facility whose construction was completed in June 2021. As a not-for-profit organization having a public interest mandate, BMC is a key player in Canada's ability to respond rapidly to future national and global health emergencies. In addition, BMC supports projects of public interest, actively contributes to the overall growth and resilience of the Canadian life sciences industry and fosters industry development and innovation through Canadian production. Designed to manufacture biopharmaceuticals such as viral vector, protein subunit and virus-like particle vaccines, as well as other biologics, BMC is helping to increase domestic biomanufacturing capacity, ensuring that vaccines and other biologics can be made safely in Canada, for Canadians. With its committed and innovative employees, BMC fosters a culture of agility and transparency with a collaborative, results-oriented approach. Join us in supporting the public health of Canadians

The BMC is looking for a **Validation Specialist (CQV)** who will contribute to the Validation Department by being responsible for maintaining the validation life cycle of the facility, utilities, systems, and equipment.

Under the supervision of the **Validation Supervisor,** the **CQV Validation Specialist** will have the following responsibilities:

- Manage validation projects related to:

- The facility, utilities, systems, and equipment and
- The integrity of the data of computerized equipment as per regulations 21 CFR Part 11 and GUI-0050 Annex 11.
- Establish the validation strategy.
- Participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), if applicable.
- Generate and/or revise validation protocols (IQ, OQ and PQ) and coordinate their approval.
- In the case where the protocols are obtained by external suppliers, perform their review and evaluate whether all qualification requirements have been met. If applicable, generate and execute complementary protocols.
- Plan, coordinate and execute validation tests and document them according to procedures in place.
- Write non-conformity reports and ensure their resolution.
- Assemble all pertinent documentation and generate validation summary reports.
- Coordinate and guide the activities of external validation consultants.
- Participate in the evaluation or implementation of controlled changes and corrective/preventive actions.
- Perform periodic reviews and requalification activities.
- Perform decommissioning activities, if applicable.
- Participate as required in regulatory inspections.
- Write and maintain procedures related to validation activities.
- Manage validation documentation (ex. prepare qualification binders and archive according to the procedures in place).
- Perform risk analyses and technical assessments.
- Contribute to the creation of controlled change requests and to the documentation of incident reports and investigations, if applicable.

**You are the person we are looking for if**:

- You have a university degree in sciences or engineering in an appropriate discipline (chemical, mechanical or equivalent).
- You have a minimum of 5 years of GMP experience in a validation position in the pharmaceutical or biotech industry. Experience in the biomanufacturing sector or in a sterile/aseptic environment is an asset.
- You have experience in writing, reviewing, and executing qualification/validation protocols, and working with protocols provided by external suppliers.
- You have experience in the qualification of manufacturing areas, utilities (clean utilities an asset), equipment (ex. bioreactors, filtration systems, filling systems, secondary packaging equipment), autoclaves, and temperature-controlled chambers and warehouses.
- You have good communication skills in both French and English (written and spoken).
- You have the capacity to work independently, have a good team spirit, and can stay organized and manage priorities.
- You have good judgment (including decision-making), critical thinking and problem-solving skills.
- You have knowledge of the investigation, deviation, change control and CAPA processes.
- You can use specialized domain-specific software, as well as Microsoft's Offices suite.
- You are familiar with occupational health and safety regulations and legislation.

**What we offer**:

- A respectful and friendly work environment in a new facility with state-of-the-art equipment.
- A competitive salary aligned with your skills.
- Attractive vacations allowances.
- A full range of benefits: group insurance, telemedicine, group RRSP and EAP.
- Hybrid schedules.
- On-site parking.

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