Engineering Projects and Compliance Manager

HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Caroline Kingston
email Caroline@hero.ie

Engineering Projects and Compliance Manager

Apply Now

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

Description

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. .

RESPONSIBILITIES

  • 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.

EDUCATION

  • 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 caroline@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Caroline Kingston

JOB-12956

Apply Now

Engineering Projects and Compliance Manager

Caroline Kingston

Role Type Permanent
Contact Caroline Kingston
email Caroline@hero.ie
mobile +353 86 839 55 31
linkedIn profile click here

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