Director, Engineering & Facility Operations, is responsible for the manufacturing systems, facilities, environmentally controlled areas and utilities. The incumbent is also responsible for leadership and development and management of maintenance and capital projects for the site.
As a member of the Engineering Leadership Team, participates in the development, articulation and implementation of good engineering at the site and meet all regulatory requirements.
Job Responsibilities:
• Develop the strategic vision of the Engineering and Maintenance departments, with the development and deliver and tracking of objectives and performance metrics.
• Responsible for an effective site-based PM and calibration program using reliability data for maintenance of assets. Implement best practices and constantly evaluate the PM and calibration programs to effectively assess impact on reliability and to identify further continuous improvement opportunities.
• Own, plan and manage the R&M budget for the site in addition to the Engineering budget and headcount allocation.
• Partner with Indirect Procurement to support vendor negotiations and contract management to ensure cost effective solutions to manage the OPEX site budget.
• Work with Site Leadership and Corporate Engineering to create and implement plans to continuously improve site infrastructure needs such as energy, water, treatment, steam and all infrastructure services, contracts and contractors; aligning with Corporate Engineering standards and practices.
• Be an active member of the Site leadership team and help support a team environment within all segments of the site to drive meeting/exceeding site objectives.
• Ensure compliance with all regulatory requirements and good documentation practices are followed to track all work and make data analysis efficient. Drive reduction in deviations by increasing awareness of cGMP practices and compliance requirements.
• Develop a strong safety culture and mindset for all those within the Engineering and Maintenance Departments.
• Develop, implement and maintain guidelines, policies and SOPs to achieve a compliant based approach to qualification, environmental mapping and engineering change management.
• Develop annual capital project expenditure and be accountable for the execution of the plan in conjunction with site leadership and organizational peers for the site that will ensure the effective utilization of capital funds to maximize organizational benefit.
• Ensure that a rigorous HAZOP and PSHSR program is adhered to for existing as well as for new or modified facilities and equipment to ensure employee safety, efficiency and compliance.
• Accountable for non-conformance investigations and continuous improvement initiatives related to equipment and facility systems.
• Oversee the Manufacturing Equipment and Facility Qualification and Validation programs to ensure that systems are qualified and validated according to the global quality management.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned.
Job Requirements:
Education
• A Bachelor of Engineering Degree or equivalent.
• Licensed Professional Engineer in Ontario is an asset.
Knowledge, Skills and Abilities
• Strong organizational, interpersonal and communication skills.
• Pharmaceutical Manufacturing with exposure to HPFBI/FDA Regulations.
• GMP Manufacturing, Packaging and facility technologies.
• Equipment Maintenance /Operations management
• PLC/Distributed Control Systems/BAS systems/Network systems
Experience
• Ten to fifteen years of experience in with a minimum 10 years’ experience in management and oversight of Engineering, Maintenance, and Qualification & Validation activities in the chemical or pharmaceutical industries, capital projects related to operation/maintenance of major facility infrastructure systems and/or production equipment with proven capital/technical leadership capability.
If interested, please contact Phil DuBois @ pdubois@prideinpersonnel.com 905-470-7618