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, Facilities, Global Track & Trace, 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 Engineering 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 engineers on engineering projects and designs.
Develops User Requirement Specifications, oversees the vendor identification and selection process, reviews bids, and selects and manages contractors for all engineering 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 Operations Management team to lead continuous improvement initiatives in terms of design engineering efficiencies, process, quality, safety and problem resolution in compliance cGMP’s.
Develops strategies for operational excellence within the Engineering team
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.
Assists in the development of and adherence to engineering 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.
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.
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.