CQV Associate (Commission,qualification,validation)

About Biodextris

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

About the position

We are currently seeking a qualified candidate for a CQV Associate. The candidate will be in charge to commission, qualify and validate equipment, utilities and systems utilized for development, manufacturing and analytical testing of clinical-phase vaccine and biotherapeutic programs.

Candidates are expected to have baseline experience in the commissioning, qualification and/or validation of bioprocessing equipment, facilities or utilities, as well as computerized systems, and in the execution of maintenance and calibration activities. Candidates 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 incumbent will report to the CQV Manager or delegate.

Position Summary



• Location: On-site role in Laval
• Employment type: Permanent, full-time (37.5 hours per week) with flexible hours
  

Key Responsibilities

• 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.
• 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 maintenance and calibration protocols and reports, 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).
• Maintain clear communications with operational departments, validation, quality assurance, and project teams as necessary.
• 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.
• Perform additional duties as assigned.
• Practice safe work habits and adheres to company safety/security procedures and guidelines.
  

Education and Experience

• Bachelor’s degree in Engineering or Life Sciences (Biochemistry, Microbiology, Chemical or Biochemical Engineering, or related field).
• Minimum of 1 year of relevant experience in CQV, validation, or a regulated biopharmaceutical environment.
• Proven experience with computerized system validation is considered an asset
  

Knowledge, Skills and Abilities:

• 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.
• Excellent organizational and communication skills, with the ability to coordinate cross-functional teams and interact effectively with internal and external stakeholders.
• 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.
• Effective written and oral communication skills as well as presentation skills
  

How to apply: