Manager, Production Tech-ENG-PTRH R

The Manager, Production Technical is responsible for leading the operability, quality compliance, safety and continuous improvement of Equipment used by Oral Solid Dosage Production, Global Research & Development, Logistics and Quality for processing Pharmaceuticals.

Responsible to manage the Preventative Maintenance program, lead Equipment Breakdown resolution, support technical aspects of Quality investigations and drive resolutions. This includes, maintaining equipment history and master data, supporting implementation of capital projects and supporting equipment and computer validation. The responsibility extends to ensuring that engineers and technical personnel are qualified to perform their duties and that the above responsibilities are properly documented and conducted according to regulatory requirements, company guidelines and procedures such as SWPs, SDs and SOPs

Provide visible leadership within the Production Technical Services areas to engineers, technical professionals and tradesmen to assist Apotex in achieving Quality, Productivity, and Safety goals.

1. Manage the respective area Maintenance teams of Production Technical, supported by the Supervisors, to ensure compliance of preventive maintenance programs and availability of parts for maintenance. Review history of breakdowns and upgrade equipment to prevent re-occurrences to improve equipment uptime.

1. Work closely with the Production, Capital Engineering, Building Services, Validation, and the Safety, Health & Environment groups to ensure Operations’ technical issues are being addressed to the required standards. Ensure the Project Leaders support Corporate Engineering’s policies, practices and long term objectives.

1. Establish an environment that promotes communication at all levels and strives to make all information available when and where needed. Provide coaching to direct reports and develop them in both technical and leadership areas.

1. Ensure correctness of master data, preventative maintenance plans and equipment history in SAP relative to production equipment and manage the upload process as required by change control processes.

1. Ensure procedures for your areas of responsibility are developed, maintained as current and that a documented training program is in place. This should include initial training of all new hires and be geared to ensure compliance with all company, industry, government and regulatory standards.
   
2. Ensure that annual job evaluations and career development plans are prepared for all employees in the department.

1. Examine and evaluate staffing levels in the Production Technical Services area to ensure that the needs of the business are met. Lead the appropriate recruiting effort to deliver the identified staffing needs.

1. Support the technical aspects of quality investigations to determine the root cause of equipment related quality notifications and drive the associated corrective and preventative actions to completion.

1. Serve as the backup to the Associate Director of Engineering as requested.

1. Works as a member of a team to achieve all outcomes.

1. Perform all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrate strong and visible support of our values.

1. All other duties as assigned.

• Bachelor’s degree in Engineering or equivalent.
• Minimum five years of experience with manufacturing equipment in the pharmaceutical industry.
• Five years of managerial experience with engineers and tradesmen.
• Excellent ability to delegate and can effect change through others without direct involvement.
• Exercises innovative tactics and encourages others to demonstrate creative approaches
• Strong organizational, interpersonal, written and communication skills.
• Proven ability to lead and motivate subordinates.
• Experience in procurement, commissioning and qualification of manufacturing and packaging equipment.
• Strong understanding of GMP requirements and their application in a manufacturing environment.
• Experience with regulatory inspections.