Engineering Projects and Compliance Manager
Job ID: JOB-12956
Engineering Projects and Compliance Manager
Finding the right company that aligns to your career aspirations and values is so important. I have a superb opportunity with a leading pharmaceutical client with a base in Galway to take on the role of Engineering Projects and Compliance Manager
This is an opportunity to be part of a dynamic team within the Engineering and Maintenance function. We are looking for individuals who will support and drive their vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers. This role involves the effective management of the Engineering project and engineering compliance team function at the site, ensuring delivery and compliance of capital projects including Buildings and Equipment, and ongoing compliance of existing buildings, utilities and equipment. As well as this, it involves performance management of the engineering compliance team, planning/execution and monitoring of project deliverables of the engineering office team including compliance management reporting to the Director of Engineering. .
- Management of the engineering office team executables including execution of capital and maintenance projects from capex application preparation to hand over to production, operational compliance to GMP including change control management, and validation life cycle documentation creation and execution, close out of internal audits, external audits, contractor engagement and scheduling, project engineering project management, corrective action and preventative action reports and specialist engineering reports.
- Management/training and guidance of the engineering office team through effective coaching/teaching and direction of the team to meet project and compliance KPI’s within the agreed budget limits.
- Management of projects to agreed timelines and costs. Projects entail capital facility and equipment alterations and additions on the campus in FDA and HPRA regulated facilities.
- Ensure contractor and project compliance to safety requirements Liaising with sub contractors/suppliers where necessary.
- Ensure compliance to documented procedures and cGMP requirements are maintained at the highest possible standards.
- Preparation of engineering procedures as required where appropriate to meet compliance requirements and/or project KPIs .
- Achievement of KPIs as outlined in Performance and Development Plan.
- Implementing suggestions for improvement of the Quality System where applicable.
- Ensuring all existing procedures which are part of our quality system are adhered to.
- Ensure validation status of the plant and facilities is maintained e.g. air handling.
- Management of service contractors such as operations calibrations.
- Degree qualified in a technical discipline
- Lead project management experience for complex projects involving multiple functions (e.g. Divisional R&D, Program Management, Regulatory Affairs, Design Assurance, Process Development, Sustaining Engineering, Global Supply Chain) and Multiple Sites
- Strong people management experience preferably in pharmaceutical or medical device industry
For further information on this Engineering Projects and Compliance Manager role please contact Caroline on 086-8395531 or email firstname.lastname@example.org
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