specialists in process validation (Int.)

FOP CONSULTANTS is looking for specialists in cleaning validation at the intermediate level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to design and execute equipment cleaning validation by establishing toxicology-based limits (PDE/MACO) and to analyze sampling results, manage deviations and maintain the validated state in compliance with GMP and regulatory requirements.

• Define the cleaning validation strategy and the grouping of products and equipment.
• Establish acceptance limits using toxicological approaches (PDE/ADE, MACO).
• Draft and execute sampling (swab, rinse) and testing protocols.
• Assess clean and dirty hold times and cleaning procedures.
• Analyze results, investigate deviations and track CAPA.
• Maintain the validated state and the continued cleaning verification program.
• Ensure compliance with GMP, Health Canada and FDA requirements and Annex 15.

• Bachelor's or Master's degree in science (chemistry, biochemistry, biology, etc.), engineering (chemical engineering) or any other related discipline.
• Five (05) to ten (10) years of industry experience.
• Three (03) to seven (07) years of experience as a Specialist in Cleaning 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.