Commission, Qualification and Validation (CQV) Associate

Biodextris is a contract development and manufacturing organization (CDMO) serving the biologics and vaccines industries. Based in Laval, QC, we are establishing a custom-designed facility to come on-line in 2024.



We are currently seeking qualified candidates for Commissioning, Qualification and Validation (CQV) Associate positions, responsible for supporting commissioning, qualification, and validation (CQV) activities for equipment, facilities and utilities utilized for development, manufacturing and analytical testing of clinical-phase vaccine and biotherapeutic programs. The incumbent will be directly supporting the preparation and start-up of our new CDMO facility.

Candidates must be capable of developing a technical understanding of bioprocessing and laboratory equipment, and comfortable with working within a highly regulated environment. Experience in validation, operation or maintenance of relevant equipment, facilities or utilities is preferred.

The incumbent will report to CQV Manager, CQV Specialist or delegate.

Duties and Responsibilities

• Execute validation deliverables such as CQV documentation, including installation, operational and/or performance qualification (IQ/OQ/PQ) for equipment, utilities and facilities, including manufacturing cleanrooms, analytical and development laboratories.
• Author and/or review documentation including CQV protocols and reports, standard operating procedures (SOPs), user requirement specifications (URS), functional and design specifications (FS/DS), risk assessments and others if applicable according to GMP guidelines.
• Coordinate activities with Validation project teams, including external consultants and service suppliers.
• Support change control, investigations, and corrective and preventative action (CAPA) activities.
• Maintain Good Documentation Practices when completing GMP documents.
• Ensure controlled and/or regulated project documents and records are initiated, advanced, completed and maintained in accordance with Biodextris’ Quality Management System (QMS) and relevant regulatory guidelines, including Good Manufacturing Practices (GMP).
• Track/monitor and provide timely, accurate information regarding status of tasks.
• Maintain personal training file.
• Perform additional duties as assigned.
• Responsible for exhibiting professional behavior with internal and external associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Practice safe work habits and adheres to company safety/security procedures and guidelines.



The above information has been designed to indicate the general nature and level of work performed by employees within these qualifications. It is not designed to contain or be interpreted as comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Qualifications

Theoretical and practical scientific knowledge and expertise/experience typical of:

• DSC/DEC or equivalent college diploma in Engineering or Life-Sciences related field; Biochemical Engineering, Chemical Engineering, Biochemistry or Microbiology or equivalent with 2+ years relevant experience.
• B.Sc/M.Sc or equivalent in Engineering or Life-Sciences related field; Biochemical Engineering, Chemical Engineering, Biochemistry or Microbiology or equivalent with 0+ years relevant experience.
• Knowledge, Skills and Abilities:
• Preferred: Experience in commissioning, qualification and validation (CQV) activities for laboratory equipment, bioprocessing equipment, cleanroom facilities and/or supporting utilities.
• Preferred: Experience working in compliance with Canadian, USA and European Good Manufacturing Practices (GMP).
• Preferred: Knowledge of biologic (large molecule) manufacturing or analytical technologies.
• Scientific mindset, with the ability to collate and comprehend technical information.
• Ability to accurately execute and document activities according to defined protocols.
• Ability to execute work under direction on schedule, and to adapt to changing priorities.
• Ability to work well with cross-functional teams and diverse groups of stakeholders.
• Knowledge of standard office software, i.e., MS Office.
• Effective written and oral communication skills as well as presentation skills.