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Engineering Director - Operations

  • Sector: Science & Pharma
  • Contact Email: rory.walsh@collinsmcnicholas.ie
  • Job Ref: 18202

Engineering Director – Operations


Reporting to the Site Lead, the successful candidate will have overall responsibility for the leadership and management of the Operational Engineering Department by ensuring that the plant meets expectations in terms of customer service and financial control. The Operational Engineering Director is a core member for the Site Senior Leadership Team (SLT). The position involves ensuring the departments within the function are directed so that their respective priorities are achieved.

 

Duties and Responsibilities:

                   Active member of the Senior Management Team contributing to the overall success and direction of the Cork site.

                   Manage all operational engineering activities so plant output targets are achieved in a compliant environment (GMP), and engineering activities comply with laws, regulations, and standards both internally and with external statuary bodies.

                   Responsible for having the necessary trained engineering resources with the appropriate skills available to maximize operational equipment uptime.

                   Trouble shooting and giving continuous technical support to the site.

                   Responsible for plant shutdowns and timely start-ups.

                   Manage the team to break out each component part of the sterility assurance system to define review and optimise the data and controls in place and the internal knowledge opportunities presented, to meet these requirements

                   Responsible for having Preventive Maintenance plans in place and agreed with Planning and Manufacturing using plant planning process that deliver increased reliability.

                   Take the overall responsibility for delivering the departments functional goals including operational uptime, compliance, financial, and people development.

                   Continue to develop Lean methodologies and in particular a GE Professional Maintenance (GPM) strategy

                   Partner with the Process and Technology Leader to develop strategic direction and resource allocation between the 2 engineering teams on site

                   Leading, motivating, developing, and managing the performance of the Engineering Functional Teams including Maintenance Engineering, Sterility Assurance, & Process Engineering (including process validation).

                   Have an ability to lead technical root cause investigations.

                   Responsible for developing people, training, and technical skills to maximise operational equipment uptime, implement new technologies and applying best practice in maintenance methods and systems.

                   Manage Continuous Professional Development for the Engineering team through education, training, and on the job experience programs.

                   Ensure all work completed by team or suppliers adheres to ESH policies

                   Ensure compliance with current technical, engineering and regulatory standards and guidelines

                   Provide Supervision to the team to optimise sterility assurance awareness and integration within the site.

                   Co-ordinate engineering activities between Maintenance Engineering, Sterility Assurance, & Process Engineering to support cost effective Engineering Structures and procedures.

                   Manage and give leadership to Energy Management (ISO50001 certified) on site.

                   Ensuring Systems, Policies and Procedures are in place and up to date to ensure maintenance activities are carried out in compliance with Environmental, Safety, Health, Good Engineering Practice, continued Good Manufacturing Practice, and other corporate standards and regulations.

                   Responsibility for authorisation and maintenance of process validation documentation and ensuring these meet regulatory requirements

                   Ensuring a process validation master plan is kept current and implemented

                   Developing and implementing systems to ensure that the plant is maintained in a validated state

                   Ensuring Validation activities are carried out in compliance with product license commitments, cGMP and company Quality standards, responsible for Process validation assessment and approval of compliance documentation

                   Manage all maintenance activities of the Cork site and ensure that maintenance activities comply with laws and regulations of local authorities and the government.

                   Have External Focus to understand business and engineering trends in the global supply chain and implement best practices in Cork site.

 

Desired Skills and Experience:

                   Degree or equivalent in Engineering and/or in a related business discipline.

                   At least 4 years’ people management experience in a pharmaceutical, device, process, or regulated industry

                   At least 10 years’ development, maintenance, process, or validation experience in a pharmaceutical, process or regulated industry.

                   At least 4 years’ experience of budget management.

                   Excellent knowledge and experience of documentation, standards, and guidelines.

                   Excellent communication skills and a proven track record in managing people on a wide range of tasks.

                   A strong working knowledge of processes such as project management, validation, automation, maintenance systems, 6 sigma, lean methodology, cost centre management, and change management processes.

                   A strong working knowledge of site plant processes including Production, Packaging, Facilities, Utilities, Logistics, Finance, EHS, Quality. 


For a confidential discussion and more information on the role, please contact Rory Walsh.

rory.walsh@collinsmcnicholas.ie

087 126956