CQV Specialist: Validation & Commissioning (Biologics)

Centre de production de produits biologiques (CPPB) inc. / Biologics Manufacturing Centre (BMC) Inc.; Montreal; Remoto; CAD 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible schedule

Remote work options

On-site parking

Descrizione del lavoro

The Biologics Manufacturing Centre (BMC) Inc. in Montréal, QC is seeking a Specialist, Validation, Commissioning and Qualification (CQV) for a ~12‑month maternity leave assignment.

You will plan, perform and document validation activities across facilities, utilities and CGxP equipment, ensuring regulatory compliance and data integrity. You will develop validation strategies, draft IQ/OQ/PQ protocols, execute testing and support regulatory audits, with French‑language fluency and English

Competenze

• Five+ years of validation experience in pharma/biotech.
• Experience drafting, reviewing, and executing GMP protocols.
• Experience in qualification projects for manufacturing areas, utilities and equipment.
• Fluent in French; ability to draft English documents for international suppliers/clients.

Mansioni

• Manage validation projects for facilities, utilities and equipment.
• Establish validation strategy and participate in FAT/SAT tests.
• Draft and review IQ/OQ/PQ protocols and coordinate approvals.
• Coordinate validation testing and document results.
• Prepare non-conformance reports and validation summaries.
• Contribute to change controls, CAPAs and requalification activities.
• Participate in regulatory audits as required.

Conoscenze

GxP validation experience

French fluency

Formazione

University degree in science or engineering

Strumenti

IQ/OQ/PQ protocols

Descrizione del lavoro

The Biologics Manufacturing Centre (BMC) Inc. is a new biomanufacturing facility created in response to the pandemic. As a non-profit organization, the BMC aims to better meet the biopharmaceutical needs of Canadians. The BMC supports projects of public interest, actively contributes to the growth and overall resilience of Canada’s life sciences industry, and fosters industry development and innovation through domestic manufacturing. Driven by its engaged and innovative employees, the BMC promotes a culture of agility and transparency, with a collaborative and results-oriented approach.

We are looking for a Specialist, Validation, Commissioning and Qualification (CQV) who will play a key role in the validation of facilities, utility and computerized systems, and equipment. This person will plan, perform, and document validation activities to ensure compliance with regulatory requirements. This is a temporary assignment of approximately 12 months to cover a maternity leave.

The Specialist, Validation, Commissioning and Qualification (CQV) will have the following responsibilities:

• Manage validation projects:
  
  
  
  • For facilities, equipment, and utility systems;
  
  
  • For the integrity of data generated by computerized GxP equipment, and ensure compliance with applicable regulatory guidance, including GUI-0050, Annex 11, and FDA 21 CFR Part 11.
  
  
• Establish the validation strategy.
• Participate in commissioning tests (FAT, SAT), where applicable.
• Draft and review validation protocols (IQ, OQ, and PQ), coordinate their approval, and, when protocols are supplied by vendors, confirm that they meet all qualification requirements and draft any required supplemental protocols.
• Plan, coordinate, execute, and document required validation testing.
• Prepare non-conformance reports and ensure their resolution.
• Compile documentation and prepare validation summary reports.
• Participate in the assessment or implementation of change controls and corrective and preventive actions.
• Perform periodic reviews and requalification activities.
• Perform decommissioning activities.
• Participate in regulatory audits as required.
• Draft and maintain procedures related to validation activities.
• Manage validation documentation (e.g., prepare qualification binders and archive records in accordance with the applicable procedure).
• Prepare risk analyses or technical assessments.
• Contribute to the creation of change control requests and the documentation of incident reports and investigations, where applicable.

You are the person we are looking for if:

• You hold a university degree in science or engineering in an appropriate discipline (chemical, mechanical, or equivalent).
• You have at least five (5) years of experience in a validation role within the pharmaceutical or biotechnology industry.
  
  
  
  • A combination of relevant education and experience may be considered.
  
  
• You have hands-on experience drafting, reviewing, and executing protocols in a GMP environment.
• You have directly participated in qualification projects involving manufacturing areas, utilities, and equipment.
• You are able to communicate fluently in French.
• You are able to draft complex documents in English, as several of our suppliers and clients are based outside Quebec.

The BMC, an employer that offers what matters to you

• A flexible schedule and remote work options
• A competitive salary aligned with your skills
• A culture of transparency, including monthly corporate meetings
• A respectful and welcoming work environment
• A new facility equipped with state-of-the-art technology
• An opportunity to participate in our various workplace committees (social club, employee committee, occupational health and safety committee, etc.)
• A wide range of activities throughout the year to connect with colleagues, celebrate team successes, and expand your knowledge
• Free on-site parking

The BMC, an organization unlike any other

• Our team is made up of talented and dedicated people from diverse backgrounds
• We strive to develop, share, and disseminate knowledge
• Our non-profit status allows us to reinvest every dollar of profit in the organization
• Our people-focused size allows every employee to help shape the organization’s growth
• Our economic positioning is unique within our industry
• Our social mission is extraordinary

The BMC, a key player in Canadian biotechnology manufacturing

The BMC is a new facility located in the heart of Montréal, whose construction was completed in June 2021. It supports the expansion of Canada’s biologics manufacturing capacity, helping ensure that vaccines and other related products can be manufactured safely here at home. With its state-of-the-art facilities and the expertise of its team, the BMC can manufacture biopharmaceutical products such as viral-vector vaccines, protein-subunit vaccines, virus-like particle vaccines, and other biologics. It is a key contributor to Canada’s ability to respond rapidly to future national and global health emergencies.