Certification Specialist Medical Devices jobs in Ontario

Pillar5 Pharma is seeking an experienced Reliability Specialist to support the reliability, performance, and long-term lifecycle management of critical manufacturing, utility, and facility assets within our GMP regulated pharmaceutical manufacturing environment. Through the application of reliability engineering, maintenance optimization, and asset management best practices, this role helps drive equipment performance, reduce downtime, support regulatory compliance, and ensure operational readiness across the site.

RESPONSIBILITIES:

• Develop and manage the site's asset reliability and lifecycle management program for manufacturing, utility, laboratory, and facility equipment.
• Establish asset criticality assessments and reliability strategies to support operational, quality, and businessobjectives.
• Monitor equipment performance, reliability trends, and asset health toidentifyopportunities for risk reduction and continuous improvement.
• Support capital planning and asset replacement decisions through equipment condition assessments and lifecycle analysis.
• Maintain asset performance data and reliability metrics within the CMMS, including analysis of downtime, MTBF, MTTR, and maintenance effectiveness.
• Optimizepreventive maintenance programs and maintenance strategies using reliability data, failure analysis, and industry best practices.
• Lead or support root cause investigations, reliability improvement initiatives, and implementation of reliability-centered maintenance (RCM) principles.
• Support maintenance-related deviations, CAPAs, change controls, audits, and regulatory compliance activities.
• Collaborate with Engineering, Maintenance, Operations, Quality, Validation, and external vendors to improve equipment reliability,maintainvalidated states, and support operational performance.
• Provide technical guidance and support continuous improvement initiatives focused on reliability, maintainability, and equipment performance.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor’s degree in engineering, Engineering Technology, or a related technical discipline; equivalent combinations of education and experience may be considered.
• 3–7+ years of experience in reliability engineering, maintenance engineering, asset management, or a related discipline within a regulated manufacturing environment.
• Experience in pharmaceutical, biotechnology, medical device, or other GMP/GxP-regulated industries is preferred.
• Strong knowledge of reliability methodologies, including Root Cause Analysis (RCA), Failure Modes and Effects Analysis (FMEA), Reliability-Centered Maintenance (RCM), and predictive maintenance practices.
• Experience with CMMS platforms (e.g., SAP PM, Blue Mountain) and maintenance planning principles.
• Understanding of critical manufacturing and utility systems, including HVAC, clean utilities, filling equipment, autoclaves, and environmental controls.
• Strong analytical, problem-solving, organizational, and communication skills with the ability to collaborate effectively across departments.
• Experience supporting aseptic manufacturing environments and professional reliability certifications (e.g., CMRP) are considered assets.

Compensation:

• $80,000 to $110,000/ year.
• Full-time, permanent employees receive full health benefits starting on Day One.

Please note that we will also be conducting a concurrent external search for this position.

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 committed to diversity, inclusion, and equal opportunity in the workplace. Accommodations are available upon request throughout the recruitment and selection process.