Production Engineering Manager

Job Summary

The Manager, Production Engineering is responsible for leading the Richmond Hill Production Engineering team through projects, shutdowns, and continuous improvement initiatives with the overarching goal of optimizing site efficiency, output, quality, safety and cost.

Responsible for managing the production engineering program at the site level, the Manager will ensure the right skillsets are available for production engineering needs. This would include: complex equipment trouble shooting, deviation investigation and root cause analysis, capital project execution, major equipment maintenance and line shutdowns, continuous improvements aligned with the site’s goals of output, quality, safety and cost reduction. The manager is accountable to ensure correct prioritization of resources to maximize positive impact on the site’s operations.

Job Responsibilities

• Provide leadership, direction and oversight to all Production Engineering team members for capital projects, shutdowns and manufacturing assistance to assist Apotex in achieving Quality, Productivity and Safety goals
• Liaise with technical professionals and end-use customers to support the development of project scope and user requirements specifications that satisfy the business need.
• OEM contracts, shutdown execution, CCRs, Qualification, PM review, downtime trending, OEE support, site priorities
• Support the development of project design basis, project justification documentation and Authorization for Expenditure.
• Prepare cost estimates, feasibility studies and execution schedules for projects and/or portions thereof assigned.
• Support resourcing and prioritization for all projects in the Richmond Hill production space, aid in the delivery of project scope within budget and schedule. Examine and evaluate staffing levels in the department to ensure that the needs of the business are met. Lead the appropriate recruiting efforts to deliver the identified staffing needs.
• Create a culture which values trust, empowerment, and provides the opportunity for Employee development.
• Demonstrate behaviours that exhibit our core organization values: Collaboration, Courage, Perseverance and Passion.
• Manage team development, including maintenance of skills matrices, cross functional training initiatives and routine feedback and performance reviews
• Act as an SME for quality-related discussions during audits/inspections; ensure qualification strategies and related SOPs are in compliance with regulatory requirements at all times
• Strong collaboration with Site and Corporate teams including Quality, Reliability, Capital Projects, Maintenance, HSE, Operations and support functions to achieve deliverables.
• Liaise with end-use customers within Apotex to research, develop and analyse problems with existing facilities/equipment at Richmond Hill and recommend solutions for improvement or redevelopment.
• Collaborate with Launch, R&D and Operations to identify new product requirements and implement engineering solutions to ensure readiness to manufacture new products.
• Support the Production, Maintenance and Complaints/Investigations groups on an as-needed basis with respect to problem solving, troubleshooting, vendor communication, and development of project designs and corrective/preventative action implementation for processes at Richmond Hill
• Co-ordinate the activities of outside consultants and contractors in the execution of design and construction work, ensuring Apotex technical and regulatory compliance standards, safety, cost and schedule parameters are maintained and reported.
• Ensure that all necessary permits and certifications as required by the current codes are obtained and that any necessary inspections and pre-start safety reviews are completed
• Act as a Subject Matter Expert with individual start up teams, ensure the appropriate commissioning, qualification and training plans, with accompanying resources, are in place to deliver efficient system start up
• Lead the development and execution of F.A.T., S.A.T., commissioning and validation and change control requirements for work assigned
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • A Bachelor of Engineering Degree or equivalent.
• Knowledge, Skills and Abilities
  • Strong understanding of GMP requirements and their application in a manufacturing environment, particularly risk-based approaches
  • Demonstrated success leading and coaching technical teams to achieve desired technical results, especially in a cross-functional and high-compliance environment
  • Critical thinking is a must with a strong desire to challenge the status quo
  • Strong organizational, interpersonal, written and communication skills and ability to deal with conflicting priorities
  • Experience with FDA/HPFBI and other regulatory agency requirements and participation in regulatory inspections
• Experience
  • Minimum five years of experience with manufacturing equipment in the pharmaceutical industry, experience with isolators, fillers or vision systems is an asset
  • Five years of managerial experience with engineers and trades people, preferably in the pharmaceutical environment

Compensation Data