Sterility Assurance Specialist

Pillar5 Pharma is a specialized aseptic manufacturer located in the Ottawa Valley Town of Arnprior, Ontario. At Pillar5, we are Building Our Future as North America's ophthalmic Centre of Excellence through best-in-class compliance, operational excellence and industry leadership. Our quality and safety trained team members work together in support of our Mission to produce reliable, high-quality eye-care products that improve and enrich the lives of our customers.

The Sterility Assurance Specialist supports the Sterility Assurance Program by ensuring environmental monitoring records are reviewed and approved in a timely manner and by supporting contamination control, training, auditing, and investigation activities within the aseptic manufacturing environment.

COMPENSATION: The salary range for this position is $62,000 to $72,000/ year.

• Comprehensive health, dental benefits effective on your first day of employment.
• Short-Term Disability (STD) and Long-Term Disability (LTD) coverage.
• Life and Accidental Death & Disbursement (AD&D) insurance.
• Company Pension Plan eligibility after 90 days of employment

What you bring to this role:

• Bachelor's degree in Microbiology, Biology, Biochemistry, or a related Life Sciences discipline.
• Minimum 2-3 years' experience in pharmaceutical microbiology, sterility assurance, environmental monitoring, or contamination control.
• Experience working in a CGMP pharmaceutical manufacturing environment.
• Working knowledge of aseptic processing, environmental monitoring, contamination control, and GMP documentation requirements.
• Strong attention to detail and ability to review technical documentation accurately.
• Excellent communication, organizational, and problem-solving skills.

What you do in this role:

Environmental Monitoring Review & Approval (Approximately 50%)

• Review and approve environmental monitoring (EM) records and supporting documentation.
• Verify accuracy, completeness, GMP compliance, and adherence to established acceptance criteria.
• Support timely release of sterile products by ensuring EM documentation reviews are completed within required timelines.
• Identify, escalate, and support investigations for atypical results, trends, and documentation discrepancies.

Sterility Assurance Support (Approximately 50%)

• Coordinate and perform initial and ongoing gowning qualifications and re-qualifications.
• Deliver training on aseptic technique, contamination control, environmental monitoring, and good documentation practices.
• Conduct personnel aseptic practice audits and provide feedback and follow-up actions.
• Support media fill activities as a qualified inspector.
• Participate in investigations, CAPAs, change controls, Environmental Monitoring Reports (EMRs), and Environmental Risk Assessments (ERAs).
• Support the cleanroom garment management program and contamination control initiatives.
• Assist with sterility assurance audits and inspection readiness activities.
• Maintain sterility assurance databases, trackers, SOPs, and training materials.

Application Process

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

Disability, Accessibility and Accommodation:

Pillar5 Pharma is committed to diversity, inclusion, and equal opportunity in the workplace. Accommodations are available upon request for candidates taking part in all aspects of the selection process. If you require accommodation, please let us know and we will work with you to support your individual needs.