Engineering Manager
Contract Pharmaceuticals
Mississauga, ON
Contract Pharmaceuticals Limited is a contract manufacturer and packager of prescription and over the counter pharmaceutical products. We are dedicated to providing comprehensive and innovative outsourcing services that exceed the uncompromising demands of the global pharmaceutical industry.

Manage the Engineering Department, to ensure organizational objectives are met in a cGMP compliant environment and in support of the Production Operations and Product Development Services teams.

SPECIFIC RESPONSIBILITIES:
Manages and directs the Engineering Department, responsible for Process Engineering, as well as Validation activities.
Responsible for the efficient day-to-day operation of all Engineering functions. Assigns, directs, prioritizes and reviews activities in terms of group resourcing, planning and scheduling.
Ensures that all Engineering activities are executed such that on-time delivery of orders and/or projects is achieved and customer expectations with respect to quality, delivery and service are met.
Liaises with Maintenance, Production Operations, Product Development Services, Quality and Commercial Operations for the purposes of coordinating the generation and execution of equipment, process, product and system’s installation, qualification and validation.
Ensures that all areas of responsibility meet or exceed regulatory requirements (ie. cGMP, Health and Safety, Environment), including documentation, training, processes and the general working area. Assists in the development and/or review of cGMP and Health & Safety Standard Operating Procedures pertaining to the operation of the Engineering team.
Develops and manages all relevant key performance indicators applicable to the Engineering group. Ensures the consistent quality of engineering output by defining standards, protocols, processes and procedures, resulting in error-free and reproducible product in compliance with governing corporate and technical standards and regulations (cGMPs).
Executes and oversees the management of all Equipment and Facility capital projects related to new equipment installation or equipment re-location. Develops and executes short, medium and long range Engineering plans in alignment with capital budgets and works closely with Facilities Manager on Facility engineering projects and design. Develops User Requirement Specifications, oversees the vendor identification and selection process, reviews bids, and selects and manages contractors for all capital projects.
Develops systems and processes to ensure project milestones are established, monitored and shared with the management team, including items such as monthly management reports, department schedules, budget (cost), progress reports, design review results, product performance results, etc.
Works with Compliance to provide updates to the Master Validation Plan, including the development of validation time lines. Oversees the preparation of protocols/documents for equipment, process and system’s qualification and validation as well as the execution of such protocols/documents. Assists in the execution of change control, qualification and validation protocols for Production Operations and Product Development.
Works with the Operations Management team to lead continuous improvement initiatives in terms of design engineering efficiencies, process, quality, safety and problem resolution in compliance cGMPs. Develops strategies for operational excellence within the Engineering team.
Participates in setting delivery dates that align with established project schedules and master production planning.
Participates in the development and execution of short and long term Facility Plans for all CPL sites.
Assists in the development of and adherence to departmental capital and operating budgets.
Assists in the development of CPL’s production capacity plans to support current and future business needs
Defines, documents and implements engineering standards for drawings, specifications, documentation control, software, manuals, test procedures, revision control, configuration management, etc.
Conducts design and project post-mortem reviews to determine lessons learned.
Develops employees by providing coaching, feedback, evaluating performance and expectations, and ensuring that adequate training is provided.
Promotes and maintains safe and healthy working conditions in his/her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures employees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
Assists in the establishment of department structure, systems, processes and measures to support the achievement of Lean manufacturing goals.
Proposes new services or approach to existing services to improve compliance or effectiveness and/or reduce costs.
Other duties as assigned.

QUALIFICATIONS:
Minimum of 7-10 years of applicable experience with 5+ years of proven engineering management experience and leadership skills with proven ability to coach, lead, motivate and develop teams.
BS Degree in Engineering, preferably in Mechanical or Chemical Engineering, P.Eng designation a must
Must be able to conceptualize complex product solutions in terms of form, fit, function, engineering effort, manufacturability and cost.
Strong understanding of Pharmaceutical Manufacturing and Packaging, GMP and cGMP
Experience working in a Pharmaceutical CMO leading engineering and technology transfer teams to deliver high quality, time sensitive projects in a customer service driven organization.
Experience with global compliance, manufacturing and technical standards.
Strong interpersonal, organizational, communication and presentation skills (written and oral).
Strong technical and maintenance background to support various maintenance and engineering activities including pharmaceutical facilities and equipment installation and qualification.
Demonstrated competencies in CPL’s core values of integrity, respect, fairness and trust.
Flexible with the ability to adapt, respond quickly and manage change in a fast paced environment.
Computer literacy is required with a strong emphasis on MS Project, Word, Excel, MS Visio and AutoCAD.

PHYSICAL DEMANDS AND WORKING CONDITIONS:
Office environment and support in production area.

CPL is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. CPL is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation polices, please contact us at hr@cplltd.com.

We thank all applicants for their expression of interest; however only those selected for an interview will be contacted. No phone calls or agencies please.