Manager, Engineering (Fixed-Term Contract 12-Month)

Resilience; Mississauga; In loco; CAD 100.000 - 138.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

RRSP/DPSP match

Healthcare

Dental care

Vision care

Life insurance

Long-term disability

AD&D

Fertility benefits

Paid vacation

Paid holidays

Parental leave top-up

Tuition reimbursement

Employee referral program

Descrizione del lavoro

Resilience Biotechnologies Inc. (RESILIENCE) is seeking a Manager, Engineering to lead a team of engineers delivering capital projects, GMP systems support, and regulatory compliance.

The role partners with Manufacturing, Quality, and Maintenance to keep the site in a state of engineering readiness and GMP compliance. The ideal candidate will have 7+ years in pharmaceutical/biotech environments, strong leadership, and expert knowledge of GMP facilities, HVAC/BAS, WFI, and regulatory inspections.

Competenze

• Demonstrated ability to lead and develop engineering teams in a cross-functional organization.
• Strong knowledge of cGMP compliance and regulatory requirements in pharmaceutical or biotechnology manufacturing.
• Demonstrated expertise in capital project delivery — design, construction, commissioning, and handover of equipment and processes.
• Experience delivering engineering services in a GMP manufacturing environment, including HVAC/BAS, utilities (WFI, clean steam), and calibration program management.

Mansioni

• Lead a team of engineers to deliver engineering support across capital projects, GMP systems, and compliance activities; establish clear priorities, manage workload and resources, and foster a high-performance team culture with defined development paths.
• Manage CapEx and operating budgets; contribute to headcount planning and resource forecasting.
• Provide regular updates to FME senior leadership and project steering committees on project status, risks, and mitigation plans, compliance posture, and team performance.
• Direct process engineering activities to resolve facility and equipment issues; integrate with Maintenance for daily operations and GMP continuity.
• Troubleshoot, optimize, and drive continuous improvement of GMP process systems (PW, WFI, CIP, clean steam, SCADA, Historian).
• Lead commissioning, qualification, and validation activities for startup and regulatory batches to ensure readiness for licensure.
• Lead feasibility, design, and EPC for capital projects; oversee renovation, construction, commissioning, and start-up of facilities and processes.

Conoscenze

People leadership

cGMP compliance

Capital project delivery

Regulatory compliance

Cross-functional collaboration

Project budgeting

Vendor management

Formazione

University degree in Engineering

P.Eng. designation

Strumenti

CMMS

Veeva

SCADA

Descrizione del lavoro

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com

As a key member of the FME leadership team, the Manager, Engineering leads a team of engineers to deliver technical, project, and compliance engineering support across the site. The role spans capital project delivery, GMP systems support, regulatory compliance, and operational engineering — partnering closely with Manufacturing, Quality, and Maintenance to ensure the site remains in a continuous state of engineering readiness and GMP compliance.

This role has a primary focus on process technical support, GMP systems reliability, and capital project delivery.

Job Responsibilities

Leadership & Team Management

• Lead a team of engineers to deliver engineering support across capital projects, GMP systems, and compliance activities; establish clear priorities, manage workload and resources, and foster a high-performance team culture with defined development paths.
• Manage and oversee CapEx and operational budget requirements within area of responsibility; provide input to headcount planning and resource forecasting.
• Provide regular updates to FME senior leadership and project steering committees on project status, risks and mitigation plans, compliance posture, and team performance.

Technical & Process Engineering Support

• Direct process engineering activities to resolve critical facility and equipment issues and provide ongoing technical support to manufacturing operations following project handover, partnering with Maintenance to integrate engineering support into daily operations and ensure uninterrupted GMP operations.
• Troubleshoot, optimize, and drive continuous improvement of major GMP process systems including PW, WFI, compressed air, nitrogen, CIP, clean steam, SCADA, Historian, and related systems.
• Commissioning, Qualification & Validation Support the production of engineering start-up batches and cGMP-compliant registration batches, ensuring regulatory readiness for product licensure.
• Lead feasibility, design, and detailed engineering for capital projects; manage renovation, construction, commissioning, qualification, and start-up of new and existing facilities, equipment, and processes.

Compliance & Continuous Improvement

• Oversee engineering compliance activities including deviation investigations, CAPAs, and change control; ensure timely closure and systemic resolution of recurring issues.
• Oversee engineering documentation, drawing management, and SOP review, maintaining records in a state of audit readiness; support regulatory inspections and internal and external audits as the FME engineering subject matter expert, including inspection readiness activities and responses to observations.

Project Management & Cross-Functional Coordination

• Manage project scope, schedule, and budget for assigned capital projects, including risk identification and mitigation planning.
• Select, negotiate, and manage vendors, contractors, and consultants; prepare RFPs for professional services and oversee deliverable quality and performance.
• Partner with Quality, Manufacturing, Regulatory Affairs, and senior site leadership to align engineering priorities with site and program needs.

Experience & Education Minimum Requirements

• Demonstrated ability to lead and develop engineering teams in a cross-functional organization, influencing others and fostering collaboration.
• Strong knowledge of cGMP compliance and regulatory requirements in pharmaceutical or biotechnology manufacturing.
• Demonstrated expertise in capital project delivery — design, construction, commissioning, and handover of equipment and processes — including management of multiple concurrent projects.
• Demonstrated ability to provide engineering and technical services in a GMP manufacturing environment, with a strong technical background in GMP facility and equipment systems including HVAC/BAS, utilities (WFI, clean steam, compressed gases), calibration program management, and CMMS.
• Strong organizational, presentation, and technical writing skills.

Preferred Requirements

• University degree in Engineering or a related field 7+ years of experience in a pharmaceutical or biotechnology environment, including direct or indirect leadership of engineers or technical staff P.Eng. designation.
• Experience in process design and development for upstream, downstream, or fill/finish biopharmaceutical manufacturing.
• Experience supporting regulatory inspections, audits, or Health Canada / FDA interactions.
• Familiarity with change control processes and quality management systems (e.g. Veeva or equivalent).

Physical & Work Environment

• Ability to travel domestically and internationally as required for Factory Acceptance Testing (FAT) or other technical activities including supplier and client site visits.
• Physical demands may include standing for extended periods, crouching/squatting, ability to lift up to 20kg (44lbs) and working in cleanroom environments with appropriate gowning requirements.

Work Schedule

The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs.

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

• Resilience offers employees a robust total rewards program including an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, paid vacation, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program.

Our target base pay hiring range for this position is $100,000.00 - $137,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge.

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

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