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 Computer System Validation (CSV) Specialist position responsible for supporting commissioning and qualification activities for computerized equipment and software systems 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 validation activities within regulated industrial pharmaceutical, biopharmaceutical, or life-sciences organizations. The incumbent will report to the CQV/Project Manager.

Position Summary

Specific tasks include:

• Write and/or review 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,).
• Execute validation deliverables such as commissioning and/or qualification documentation, including 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 to meet current GMP regulations and guidelines, industry best practice and company policy.
• Participate in the execution of the periodic qualification program.
• 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.
• Assist in the selection process of new competitive equipment procurement.
• 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 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 Life-Sciences related field; Biochemical Engineering, Chemical Engineering, Biochemistry or Microbiology or equivalent with 3+ years relevant experience.

Knowledge, Skills and Abilities:

• Experienced in authoring/execution of CSV protocols for computerized hardware/software implicated in the operation of laboratory equipment, bioprocessing equipment, facilities and utilities.
• Knowledge of relevant industry/regulatory guidelines specific to computerized systems including GAMP, FDA 21 CFR part 11, EMEA GMP Annex 11.
• Demonstrated experience working in compliance with Canadian, USA and/or 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 MS Office software suite.
• Effective written and oral communication skills.

Application: Send resume and cover letter by email to info@biodextris.com.