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 Commission, Qualification and Validation (CQV) Specialist position responsible for supporting commissioning, qualification, and validation (CQV) activities for equipment, facilities and utilities utilized for development, manufacturing and analytical testing of the clinical-phase vaccine and biotherapeutic programs.
Candidates are expected to have demonstrated experience in the execution of validation activities within regulated industrial pharmaceutical, biopharmaceutical, or life-sciences organizations. The incumbent will report to the CQV/Project Manager.
Specific tasks include:
- 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.
- Provide technical support and expertise to the end users and quality resources.
- Provide technical support for the execution of the periodic qualification program, including calibration and preventative maintenance 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 the status of tasks.
- Coordinate with other departments and management to optimize validation processes.
- Maintain personal training file and assist in training of other staff.
- 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
Education and Experience:
Theoretical and practical scientific knowledge and expertise/experience typical of:
- Eng, B.Sc/M.Sc or equivalent in Engineering or Life-Sciences related field; Biochemical Engineering, Chemical Engineering, Biochemistry or Microbiology or equivalent with 2+ years relevant experience.
Knowledge, Skills and Abilities:
- Experienced in the execution of CQV protocols for laboratory equipment, bioprocessing equipment, cleanroom facilities and/or supporting utilities.
- 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.
- 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.
Application: Send resume and cover letter by email to firstname.lastname@example.org.