Critical Engineering Technician
Stream Data Centers
Associate Director, GMP Facilities
BlueRock Therapeutics
full-time
Posted on:
Location Type: Office
Location: Toronto • 🇨🇦 Canada
Visit company websiteJob Level
Senior
About the role
- Manage asset life cycles for GMP manufacturing equipment, utilities, facility and HVAC.
- Provide the necessary technical expertise for troubleshooting and resolving problems with Production Unit processes and equipment; collect, analyze and report equipment downtime information; ensure resolution of critical equipment items. Perform Risk Assessments and resolution of risk analysis.
- 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 (SME).
- 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 the Calibration, Maintenance and Safety procedures in defined area of responsibility.
- Direct and supervise the BlueRock facilities team. Manage employees, contractors and consultants as required to maintain safe and operational facilities.
- Engineering lead in 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 for contractor management strategies to identify and mitigate hazards.
- Schedule and execute maintenance activities including plant shutdowns; plan/execution of both OPEX & CAPEX projects and supporting technology transfer.
- Serve as technical system owner of BlueRock’s Computerized Maintenance Management System (CMMS), Environmental Monitor Solution and Building Management System; maintain GMP compliance, execute remediation, perform routine system data reviews, alarm response & notifications and stakeholder management of impacted users.
- Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees and team members, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area.
- Report to the VP Engineering & MSAT and be a member of the Engineering & MSAT leadership team.
- Act as anchor/on-site leader and provide leadership to License to Operate (LTO) topics within the facility (Safety and Quality).
Requirements
- 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 knowhow.
- Experience building budgets and maintaining control of area of fiscal responsibility.
- Demonstrated understanding of EHS risk management and demonstrated experience integrating 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 is able to quickly adapt to changing priorities.
- Flexibility to support business requirement 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.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMP manufacturingqualification engineeringtroubleshootingrisk assessmentbudget managementFATSATCommissioningProcess Control SystemscGMP requirements
Soft skills
interpersonal skillsplanning skillsorganizational skillscommunication skillsleadershipconflict resolutionflexibilityadaptabilitygoal settingperformance reviews
