Job Description
The Manufacturing Engineering Manager is responsible for leading the site Manufacturing Engineering team and providing technical and people leadership in support of pharmaceutical manufacturing operations. This role oversees Engineering activities throughout the equipment lifecycle, including process and equipment design, procurement, installation, commissioning, qualification, validation support, process improvement, and ongoing lifecycle management.
The Manufacturing Engineering Manager establishes functional priorities and engineering plans that support short and long term site objectives while ensuring equipment and processes are safe, reliable, maintainable, and compliant with current Good Manufacturing Practices, applicable regulatory requirements, and Good Engineering Practices.
The role provides leadership across capital projects, manufacturing improvements, compliance initiatives, and commissioning and qualification programs while developing the technical capability of the Engineering team and ensuring effective collaboration with Manufacturing, Quality, Validation, Maintenance, Automation, Capital Projects, and other site functions.
Key Responsibilities:
- Lead, develop, and manage a team of Engineers and Engineering technical personnel responsible for supporting manufacturing equipment, processes, commissioning and qualification, and equipment lifecycle activities.
- Establish team priorities, assign resources, manage workloads, and develop short and long term plans that align Engineering activities with manufacturing requirements, compliance commitments, capital projects, and site objectives.
- Coach and develop Engineering personnel through technical mentoring, regular feedback, performance management, development planning, and delegation of progressively more complex Engineering responsibilities.
- Provide technical leadership and oversight for Engineering projects from initial scope development through design, procurement, construction, commissioning, qualification, and turnover to Manufacturing.
- Lead and participate in Engineering design reviews to ensure equipment and systems meet user requirements, process requirements, cGMP expectations, applicable codes and standards, sanitary design principles, safety requirements, and Good Engineering Practices.
- Develop and oversee commissioning and qualification strategies for new and modified manufacturing equipment and systems, ensuring activities are risk based, scientifically justified, appropriately documented, and aligned with site validation requirements.
- Review and approve Engineering documentation including User Requirement Specifications, design documents, commissioning and qualification plans and protocols, technical assessments, change controls, investigations, turnover packages, and equipment lifecycle documentation.
- Provide technical oversight and Engineering judgement during equipment startup, commissioning, qualification, troubleshooting, process improvement, and resolution of complex equipment or process issues.
- Ensure manufacturing equipment remains in a qualified and compliant state through effective lifecycle management, including calibration, preventative maintenance, requalification, temperature mapping, cleaning and sterilization qualification, and management of equipment changes.
- Lead or support investigations, deviations, nonconformances, CAPAs, audit observations, and regulatory commitments requiring Engineering involvement, ensuring appropriate root cause evaluation and implementation of technically sound corrective actions.
- Support regulatory inspections and customer audits as an Engineering subject matter expert and ensure Engineering documentation, qualification records, drawings, and equipment lifecycle information remain accurate and inspection ready.
- Collaborate with Manufacturing, Quality Assurance, Validation, Maintenance, Automation, Technical Operations, Capital Projects, and other stakeholders to establish engineering priorities and resolve technical or operational challenges.
- Manage external Engineering consultants, equipment vendors, contractors, and service providers as required to support engineering projects and site objectives.
- Develop project scopes, schedules, resource plans, cost estimates, and budgets. Monitor project performance and identify technical, schedule, cost, and compliance risks requiring corrective action or escalation.
- Support site capital planning and capacity planning by evaluating equipment capability, facility requirements, engineering resources, operational needs, and opportunities for process improvement.
- Identify and implement improvements to manufacturing processes and equipment that increase reliability, repeatability, capacity, maintainability, automation, and operational efficiency while maintaining product quality and regulatory compliance.
- Support Process Hazard Assessments and other engineering risk assessments and ensure projects comply with applicable occupational health and safety requirements, environmental requirements, building codes, engineering standards, and site procedures.
- Develop, maintain, and continuously improve Engineering procedures, standards, tools, and work processes to promote consistent and effective execution across the Engineering function.
- Provide regular updates to site leadership regarding engineering priorities, project status, resource requirements, budgets, compliance activities, risks, and departmental performance.
Preferred Skills:
- Strong knowledge of cGMP requirements, Good Engineering Practices, commissioning and qualification principles, and equipment lifecycle management within pharmaceutical or biotechnology manufacturing.
- Working knowledge of applicable Health Canada, FDA, ICH, and other regulatory requirements and guidance relevant to pharmaceutical manufacturing equipment and facilities.
- Strong understanding of process equipment, instrumentation, automation, utilities, cleaning and sterilization systems, and sanitary equipment design.
- Demonstrated ability to evaluate complex technical problems, assess risk, exercise sound engineering judgement, and develop practical solutions within operational and regulatory constraints.
- Strong project and program management capabilities, including planning, budgeting, scheduling, risk management, resource allocation, and prioritization.
- Demonstrated ability to lead, coach, and develop technical personnel and establish a culture of accountability, collaboration, continuous improvement, and technical excellence.
- Excellent written, verbal, and presentation skills with demonstrated ability to communicate technical information effectively across Engineering, Manufacturing, Quality, senior leadership, vendors, and regulatory personnel.
- Strong organizational skills with the ability to manage multiple projects, compliance activities, and operational priorities concurrently.
Qualifications
Education
- Bachelor’s degree in Engineering from an accredited Engineering program.
- Registered as a Professional Engineer in Canada or eligible for registration with Engineers Nova Scotia.
Experience
- 5+ years of progressively responsible Engineering or related technical experience within a GMP regulated manufacturing environment. Pharmaceutical, biotechnology, or other highly regulated manufacturing experience is preferred.
- 2+ years experience leading or managing technical personnel, Engineering teams, projects, or programs, with demonstrated experience in employee development, workload planning, and technical oversight.
- Demonstrated experience with the design, installation, commissioning, qualification, validation support, and lifecycle management of manufacturing equipment and systems.
- Demonstrated experience leading engineering projects and coordinating multidisciplinary teams through design, construction, commissioning, qualification, and operational turnover.
- Experience developing and executing commissioning and qualification strategies within a regulated manufacturing environment.
- Experience managing project budgets, schedules, resources, consultants, contractors, equipment vendors, and competing project priorities.
- Experience supporting GMP investigations, change controls, CAPAs, regulatory commitments, audits, or regulatory inspections.
Additional Details
This job has a full time weekly schedule.
The full-time equivalent pay range for this position is $107,731.00 - $168,330.00/yr CAD plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Travel Required:
Occasional
Shift:
Day
Duration:
No End Date
Job Function:
Manufacturing
