Maintenance and Calibration Coordinator 

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 Maintenance and Calibration Coordinator position responsible for delivery of maintenance, calibration and related services for equipment, facilities and utilities utilized for development, manufacturing and analytical testing of clinical-phase vaccine and biotherapeutic programs.



Candidates are expected to have demonstrated experience in the execution of maintenance and calibration activities within regulated industrial pharmaceutical, biopharmaceutical, or life-sciences organizations. The incumbent will report to the VP Process Services or delegate.

Position Summary 

• Ensure maintenance deliverables such as preventative maintenance, fault repair, and calibration activities are executed according to schedule for equipment, utilities and facilities, including 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 GMP guidelines.
• Coordinate activities and maintain clear communications with operational departments, validation, quality assurance, and project teams as necessary.
• Schedule and coordinate external consultants and service suppliers to ensure equipment, utilities and facilities are maintained in the appropriate operating status.
• Provide first-line technical support and expertise to operational departments for equipment fault evaluation. 
• Support the commissioning, qualification and validation (CQV) program.
• 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.
• Co-ordinate with other departments and management to optimize maintenance 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. 

Qualifications

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

• 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 5+ years relevant experience.

Knowledge, Skills and Abilities:

• Experienced in execution of maintenance and calibration services 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.