Associate Director, GMP Facilities

Associate Director, GMP Facilities (Toronto, Ontario) BlueRock Therapeutics LP is a clinical stage cell‑therapy company harnessing the power of universal pluripotent stem cells to develop a pipeline of medicines for neurological and ophthalmic diseases. The company’s culture is defined by courage, urgency, integrity and community‑mindfulness, with a commitment to advance cutting‑edge therapies that impact patients’ lives. Pay Range CA$150,000.00/yr – CA$175,000.00/yr Key Responsibilities Manage asset life cycles for GMP manufacturing equipment, utilities, facility and HVAC. Provide technical expertise for troubleshooting and resolving production unit processes and equipment issues; collect, analyze, and report equipment downtime information; ensure resolution of critical equipment items. Perform risk assessments and risk analysis resolution. Understand and maintain the CMMS, EMS & BMS; develop and monitor alarms as appropriate. Resolve quality action items and write engineering assessments as subject‑matter expert. Coordinate maintenance activities and shutdown requirements for production equipment and facilities. Develop, review and implement recommendations to improve reliability of infrastructure and production systems; maintain calibration, maintenance and safety procedures within the area of responsibility. Direct and supervise the BlueRock facilities team; manage employees, contractors and consultants to maintain safe and operational facilities. Lead support for audits conducted by internal and external agencies. Support a proactive EHS culture by ensuring timely closure of EHS actions and maintaining alignment with regulatory and internal standards. Partner with EHS to create job safety analysis workflow for non‑routine work and contractor‑management strategies to identify and mitigate hazards. Other duties as assigned. Qualifications Bachelor’s degree or higher in life sciences field with 13+ years of experience, including 11+ years in a biopharma setting, or no degree and 14+ years of experience. Experience with regulatory and cGMP requirements for aseptic pharmaceutical manufacturing. Experience with qualification engineering. Demonstrated understanding of industry guidelines, regulatory requirements and relevant SOPs. Experience with CMMS, EMS & BMS systems. 21CFR Part 11 knowledge. Experience building budgets and maintaining control of area of fiscal responsibility. Demonstrated understanding of EHS risk management and integration of EHS principles into facilities management. Demonstrated ability to troubleshoot complex equipment/systems and supporting utility services. Ability to troubleshoot equipment failures immediately and communicate status to engineers and production. Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments. Strong interpersonal skills to effectively communicate with a diverse wide customer base. Strong planning and organizational skills. Good oral and written communication skills. High level of urgency and ability to adapt quickly to changing priorities. Flexibility to support business requirements of rotational on‑call support and/or weekend coverage. Experience with FAT, SAT, commissioning and qualification, including hands‑on experience starting‑up and running new equipment, resolving technical equipment issues, developing turn‑over packages. Experience with process control systems, including DCS, PLC, instrumentation and low‑voltage electrical systems. Proficient computer skills to include Excel, Word and PowerPoint; SAP experience helpful. Equal Opportunity Workplace At BlueRock, we welcome and support differences and diversity and are proud to be an equal‑opportunity workplace. Please let us know if you require disability‑related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.We may use artificial intelligence (AI) tools to support parts of the hiring process. Final hiring decisions are ultimately made by humans. Company Culture Highlights Winner of Boston Business Journal's Best Places to Work (Mid‑size Company) 2023 Winner of Comparably's Award for Best Company for Diversity 2022 Winner of Comparably's Award for Best Company for Women 2022 Winner of Comparably's Award for Best CEO 2022 BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably. Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably. Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics Follow us on LinkedIn: https://www.linkedin.com/company/bluerocktx/ #J-18808-Ljbffr