CQV Team Leader

Position Summary & role expectations

Biodextris is a contract development and manufacturing organization (CDMO) serving the biologics and vaccines industries. Our facilities are based in Laval, QC. 

We are currently seeking a qualified candidate for a CQV team leader position responsible for leading the CQV team / external resource while ensuring that equipment, utilities and systems utilized for development, manufacturing and analytical testing of clinical-phase vaccine and biotherapeutic programs are commissioned, qualified and validated, to ensure accuracy and reliability.

Candidates are expected to have demonstrated senior experience in the commissioning, qualification and/or validation of bioprocessing equipment, facilities or utilities, as well as computerized systems. Candidate must have proven knowledge of bioprocessing technologies and related quality control (QC) analytical techniques, with substantial experience within regulated industrial biopharmaceutical or life-sciences organizations. The qualified candidate will work closely with cross-functional teams to schedule, track, and complete validation activities in accordance with regulatory requirements and industry best practices. The incumbent will report to the CQV Manager or delegate.

Position Summary

Specific tasks include:

• Coordination and execution of CQV deliverables including commissioning documentation, installation, operational and/or performance qualification (IQ/OQ/PQ) for equipment, utilities and facilities, including manufacturing cleanrooms, analytical and development laboratories.

• Coordination and execution of CQV deliverables including commissioning documentation, installation, operational and/or performance qualification (IQ/OQ/PQ) for computer, computerized equipment (automated systems) and cloud-based systems used in manufacturing cleanrooms, analytical and development laboratories.

• Author and/or review documentation including qualification protocols, standard operating procedures (SOPs), equipment logs, and others as applicable according to Biodextris’ Quality Management System (QMS) and relevant regulatory guidelines, including Good Manufacturing Practices (GMP). 

• Manage the preparation and approval of CQV procedural documents and deliverables in accordance with Biodextris’ Quality Management System (QMS) and relevant regulatory guidelines, including Good Manufacturing Practices (GMP).

• Review and approve CQV documentation including validation plans, 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 relevant guidelines (e.g., GAMP, 21 CFR part 11). 

• Coordinate activities with Validation project teams, including external consultants and service suppliers.

• Maintain clear communications with operational departments, validation, quality assurance, and project teams.

• Provide regular CQV project status updates related to progress, timelines, changes, technical and/or quality issues to colleagues and management. 

• Assist in the investigation of equipment-related deviations, out-of-specification results, and nonconformances, and provide technical support to resolve issues and prevent recurrence. 

• Support change control, investigations, and corrective and preventative action (CAPA) activities.

• Maintain Good Documentation Practices when completing GMP documents. 

• Assist and provide training to other staff.

• Perform additional duties as assigned. 



• 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.

Education and experience

• B.Eng, B.Sc/M.Sc or equivalent in Engineering or Life-Sciences related field; Biochemical Engineering, Chemical Engineering, Biochemistry or Microbiology or equivalent with minimum of 5 years of relevant technical experience.

Skills, Knowledge, and Abilities 

• Excellent organizational and communication skills, with the ability to coordinate cross-functional teams and interact effectively with internal and external stakeholders

• Demonstrated experience in leading commissioning, qualification and validation (CQV) projects involving pharmaceutical and/or biopharmaceutical facilities, equipment and utilities, including computerized systems 

• Demonstrated expertise with biologic (large molecule) manufacturing technologies, including cell banking, microbial/mammalian culture technologies, downstream purification methods, including IEX, HIC, SEC Chromatography, Tangential Flow Filtration, and product formulation for various delivery route(s). 

• Strong analytical and problem-solving skills, with the ability to troubleshoot equipment issues and implement effective solutions.

• Familiarity with deviations, change controls, CAPAs, SOPS and/or Batch Records in relation to regulated manufacturing activities.

• Demonstrated experience working in compliance with Canadian, USA and European Good Manufacturing Practices (GMP). 

• Ability to work independently and flexibly and to adapt to changing priorities.



• Knowledge of standard office software, i.e., MS Office.