Maintenance Scheduler (cGMP)

Job Description

Maintenance Scheduler (cGMP)

Client: Innovative Biotech Start-up

Contract/Perm & duration: 12-month contract

***Contract will be onsite***

Location: Downtown Toronto

Based in Toronto, Ontario, the Maintenance Scheduler, Lab Operations & Facilities, will play a critical role in ensuring the reliability and regulatory compliance of manufacturing and laboratory equipment in a GMP environment. Reporting to the Associate Director, Lab Operations & Facilities, the successful candidate will be responsible for developing, coordinating, and managing preventive and corrective maintenance schedules for cGMP, supporting the overall availability and performance of critical systems. The Scheduler works closely with Operations, Engineering, Manufacturing, Quality, Procurement, Supply Chain and external vendors to ensure timely execution of maintenance activities while minimizing impact on operations and maintaining strict adherence to cGMP standards.

This is an outstanding opportunity to contribute to bringing a new class of cell-based medicines to patients. Collaboration with a highly motivated, world-class team of scientists and engineers promises an exciting and engaging work environment for a motivated, self-starting candidate.

Responsibilities:

• Develops and manages comprehensive preventative maintenance (PM) schedules for lab equipment assets using CMMS, ensuring critical assts remain operational with minimal disruption.
• Schedules corrective and calibration work orders in coordination with key internal stakeholders and external service providers.
• Prioritizes and adjusts maintenance activities based on equipment criticality, production schedules, and compliance requirements
• Estimates labor hours, skillsets, parts, materials, equipment and special tools required to complete proactive jobs in a safe and efficient manner.
• Conducts routine planning & scheduling meetings with Production and Quality Control to determine work order priorities, communicate work order status and alter planned maintenance activities if necessary.
• Principal contact and liaison between facilities, operations, supply chain, external vendors, and other supporting departments for equipment maintenance.
• Ensures all scheduled activities comply with regulatory requirements and site policies.
• Monitors work order progress and completion and escalates delays or conflicts as needed to appropriate stakeholders.
• Maintains accurate records of maintenance schedules, histories and documentation, in alignment with cGMP guidelines.
• Generates reports on PM completion rates, overdue work orders, and performance metrics for continuous improvement.
• Supports Operations and Facilities with planned facility shutdowns.
• Support audits and inspections by ensuring maintenance documentation is complete, accurate and readily retrievable
• Participates in root cause investigations as needed.
• Trains site employees on CMMS and ensure that it is working with integrity and is being utilized effectively.

Key Qualifications:

• Bachelor’s degree in Engineering, Facilities Management, Life Sciences, or related field (or equivalent experience).
• 2-5 years of experience in maintenance scheduling or planning in a cGMP-regulated environment
• Strong knowledge of CMMS systems.
• Familiarity with FDA and cGMP regulations
• Excellent organizational, communication and collaboration skills.
• Ability to manage multiple priorities in a fast-paced, regulated environment.
• Strong attention to details and a commitment to documentation accuracy and data integrity.
• Self-starter, demonstrating initiative, a positive attitude, and the ability to work in an independent and organized manner.
• Anchor role with on-site presence required. Evening, weekend/holiday work required at times due to nature of role.