specialists in equipment and system validation (Sr.)

FOP CONSULTANTS is looking for specialists in computer system validation at the senior level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to validate GxP computerized systems in accordance with GAMP 5 and a risk-based approach, to ensure compliance with 21 CFR Part 11, Annex 11 and ALCOA+ principles and to manage changes, periodic reviews and the validated state of systems in collaboration with IT and quality assurance. The senior scope is further to define the site validation strategy and arbitrate technical choices and to mentor intermediate consultants and review their deliverables.

• Define the computerized systems validation strategy in accordance with GAMP 5 and a risk-based approach.
• Draft user requirements, risk assessments and traceability matrices.
• Develop and execute verification protocols (IQ/OQ/PQ, CSA).
• Assess compliance with 21 CFR Part 11, Annex 11 and data integrity (ALCOA+).
• Manage changes, deviations and system requalification (LIMS, MES, ERP, SCADA).
• Conduct periodic reviews, supplier audits and access controls.
• Collaborate with IT, quality assurance, users and suppliers.
• Define the site validation strategy and arbitrate technical choices.
• Mentor intermediate consultants and review their deliverables.
• Represent the client during regulatory inspections and audits.

• Bachelor's or Master's degree in engineering (computer science, software, automation, industrial, chemical, mechanical), computer science, pharmaceutical sciences or any other related discipline.
• Minimum ten (10) years of industry experience.
• Eight (08) to fifteen (15) years of experience as a Specialist in Computer System Validation.
• Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
• Tools and systems: MS Office suite, Veeva Vault, TrackWise, Kneat, MS Project.
• Hold one of the following certifications: ASQ CQE, ISPE GAMP 5, Six Sigma Green Belt.
• The following are considered assets: PMP, ASQ CQA, Six Sigma Black Belt.
• Experience in Canadian public or private organizations.
• Language: French and English

• Remote, Hybrid, On-site

At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:

• Competitive compensation that reflects your expertise;
• Complete protection through our group insurance plans;
• Professional liability insurance so you can practise with confidence;
• Remote-work flexibility, based on client needs;
• 3 weeks of vacation to recharge;
• 3 paid sick days, to take care of yourself;
• A monthly allowance for your transportation costs;
• Real opportunities for advancement within the organization;
• Ongoing access to training to grow your skills.