• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     info@prochem.ie
  • Project Process Engineer – Co. Cork

    Role Summary:


    • Our client is currently looking for a Project Process Engineer to join their team in Co. Cork.
    • The Project Process Engineer will be reporting to the Wet Processing Project, Project Manager.
    • The client is investing in the delivery of a new state of the art facility for their pharmaceutical product’s API wet processing. The successful candidate will play a key role in delivering this project for the value stream and additionally supporting other global projects.
    • This person will bring current understanding of process engineering to enable the construction completion, commissioning and qualification and process qualification of the new facility.
    • As Project Process Engineer you will be the primary process representative responsible for your projects. You will be trusted to make the process engineering reviews, approvals and decisions as part of various project teams – and you will do it via a constructive dialogue founded within a pragmatic understanding of the business’ needs.
    • You will be based on site in Cork, within the existing Wet Processing Project Team and delivering as required by Good Manufacturing Practice (GMP) in a stick-built API facility. These activities include, ensuring user requirement and design intent are transferred through the construction, C&Q and PQ/PV phases of the project.


    Core Duties and Responsibilities:


    • Ensure that state of the art cGMP standards are implemented on the project
    • Ensure compliance with quality and industry regulatory requirement
    • Provide professional and timely inputs/directions
    • Prepare data/reports to communicate outcomes of process engineering activities.
    • Attend meetings and provide prompt response to problems and information needs identified
    • Ensure update of process engineering documentation: write procedures and directions for recording and reporting data in projects, for documentation owned by process engineering departments.
    • Ensure the link between Project Manager and Users Responsible on site.
    • Preparation/Reviewer/Approver of Technical Change Controls.
    • Process Engineering oversight of engineering activities on the project
    • Follow site EHS procedures.


    Minimum Qualifications and Experience:


    • Minimum qualification of a Bachelor’s Degree in a scientific/technical discipline required
    • 7 years’ + experience working with quality and cGMP in the pharma industry.
    • API Experience needed
    • Experience in Design and Construction Engineering, C&Q and life cycle qualification/validation support.
    • Experience working across a Global business a distinct advantage
    • Skilled in the use of a variety of problem-solving techniques
    • Experience in the current Quality and regulatory standards by FDA. EudraLex etc.
    • Enjoy working closely with your stakeholders and have a hands-on operational approach
    • A good communicator and when collaborating on a given task you contribute with a positive and constructive attitude.
    • Work independently with strong personal drive
    • Strong attention to detail and organisational skills
    • Have the ability to critically assess issues and devise and execute appropriate solutions using problem solving techniques in a decisive manner.
    • Strong business mindset


    To Apply:


    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    GC North Valley Business Centre, Cork, T23 KC67, Ireland.

    +353 21 2066178

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.