specialists in equipment and system validation (Sr.)

FOP CONSULTANTS is looking for specialists in equipment and system validation at the senior level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to plan and execute the qualification of equipment, utilities and systems (IQ/OQ/PQ) using a risk-based approach, to manage deviations, changes and requalification and to document results and maintain the validated state in compliance with GMP and Health Canada and FDA requirements. The senior scope is further to define the site validation strategy and arbitrate technical choices and to mentor intermediate consultants and review their deliverables.

• Develop validation master plans, qualification protocols and risk assessments (URS, FAT/SAT, IQ/OQ/PQ).
• Execute qualification testing of equipment, utilities and systems in accordance with GMP.
• Assess the impact of changes and define the requalification strategy.
• Document deviations, investigate non-conformances and track CAPA.
• Draft qualification reports and maintain the validated state of equipment.
• Collaborate with engineering, production, maintenance and quality assurance.
• Ensure compliance with Health Canada and FDA requirements, Annex 15 and the ISPE guide.
• 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 (chemical engineering), Science or in any other related field.
• Minimum ten (10) years of industry experience.
• Eight (08) to fifteen (15) years of experience as a Specialist in Equipment and 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.