Validation Supervisor

Tailor Your Resume for this Job

Company Overview

Join Pillar5 Pharma, a trusted pharmaceutical manufacturer specializing in sterile ophthalmic products that help improve patients’ vision and quality of life. From our facility in Arnprior, our team is dedicated to producing safe, high-quality products while maintaining the highest standard of quality, compliance, and operational excellence.

Summary

Pillar5 Pharma is seeking a Validation Supervisor to lead the planning, execution, and maintenance of validation activities for facilities, utilities, equipment, processes, cleaning, and computerized systems to ensure compliance with cGMP and regulatory expectations (e.g., Health Canada, FDA, EMA). This role provides technical leadership and guidance to the validation team and ensures that validation documentation is accurate, complete, and audit ready. This role works closely with Production, Engineering, QC, and QA to keep the site in a validated state throughout the product lifecycle.

RESPONSIBILITIES:

• Lead and schedule process, equipment, facility, and cleaning validation activities in alignment with the site Validation Master Plan and production schedule.
• Supervise validation specialists and contractors, assign tasks, provide technical guidance, and ensure work is performed compliantly on the manufacturing floor.
• Develop, review, and approve validation documents (risk assessments, URS, IQ/OQ/PQ protocols, reports, revalidation plans) for manufacturing and packaging lines, utilities, facilities and computerized systems.
• Support the coordination of validation when new products, processes, or equipment are introduced, and when significant changes or transfers occur, in accordance with GMP and internal change‑control procedures.
• Oversees critical aseptic validation activities such as Media Fill Performance Qualifications, Steam Sterilizer qualification, and other critical programs such as Gamma Irradiation of ophthalmic components.
• Coordinate process validation/PPQ batches, including protocol approval, sampling, data review, and final reporting, ensuring that critical quality attributes and process parameters are adequately controlled.
• Monitor the ongoing validated state through periodic reviews, requalification, and trend analysis of deviations, CAPAs, and change controls related to manufacturing equipment and processes.
• Support regulatory inspections and customer audits by presenting validation strategies and providing protocols, reports, and rationales for critical decisions.
• Partner with QA and QC to ensure data integrity, proper archiving of validation records, and alignment between validation, qualification, and routine GMP documentation.
• Contribute to continuous improvement by optimizing validation approaches (e.g., risk‑based, lifecycle), standardizing templates, and improving coordination with Production and Engineering Plan, schedule, and oversee validation projects (equipment, utilities, processes, cleaning, computer systems) in accordance with site and corporate validation master plans.

QUALIFICATIONS

• Bachelor’s degree in engineering, Life Sciences, or related field, or equivalent pharma manufacturing experience.
• 3-5 years of hands‑on experience in validation/qualification within a GMP pharmaceutical manufacturing environment, with specific experience in aseptic validation, equipment, facility and utility validation, and CSV validation.
• Strong understanding of cGMP, ICH, Health Canada, FDA, and EU expectations for process, cleaning, equipment, facility, and computer system validation.
• Experience leading or supervising validation personnel or project teams in a manufacturing plant environment.
• Proficiency with risk‑based validation, change control, deviation/CAPA management, and statistical data analysis for validation studies
• Minimum of 3–5 years managing cross-functional projects, with proven on-time, on-budget delivery.
• Technical expertise in process, cleaning, equipment, and utility validation for pharma manufacturing.
• Strong leadership and coordination skills to balance shop‑floor realities with regulatory expectations.
• Excellent written documentation skills for clear, defendable protocols, reports, and rationales.
• Ability to interpret and apply current regulatory guidance to practical validation strategies to support business and production needs.

This posting is for an existing vacancy. Pillar5 Pharma does not use AI at any stage of the recruitment or hiring process.

Pillar5 Pharma is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy or any other protected characteristic as outlined by federal, provincial or local laws.

Pillar5 Pharma welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

Job Type: Full-time

Pay: $100,000.00-$120,000.00 per year

Benefits:

• Dental care
• Extended health care
• Paid time off
• RRSP match

Work Location: In person