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

    Role Summary:

     

    • A new opportunity has arisen for an experienced Process Engineer at our client’s pharmaceutical site in Athlone, Co. Westmeath.
    • The successful candidate is responsible for the performance of the process equipment on site.
    • The Process Engineer will provide key technical support in the areas of yield improvement, reliability, process control, manufacturing process troubleshooting and product transfer.

     

    Core Duties and Responsibilities:

     

    • Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
    • Prioritises safety and is diligent in the use of all appropriate safety tools and permits when maintaining equipment – champions safe working always.
    • Is the process SME for the new product introduction process and supports manufacturing and maintenance in the operation and maintenance of these systems.
    • Is the process SME for the products, supporting or leading product related deviations, change controls and CAPAs.
    • Supports manufacturing by leading/supporting deviation investigations, and is familiar with structured problem solving and root cause analysis.
    • Supports validation activity in process manufacturing areas.
    • Leads continuous improvement projects and initiatives and is owner of yield performance and cycle time improvement.
    • Is the process equipment SME, supporting batch manufacturing activities.
    • Responsible for managing the introduction of new consumable materials into the GMP cleanrooms.
    • Provides technical support for product APRs (Annual Product Review).
    • Provides training and mentoring to build technical capabilities among teams.
    • The role will typically require infrequent, off site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time.

     

    Minimum Qualifications and Experience:

     

    • Bachelors Degree in Engineering, Pharmaceutical Sciences, or related Science discipline.
    • Further qualification (Masters) in related discipline ideal.
    • At least 5 years relevant experience in a pharmaceutical manufacturing environment, with at least 3 years experience in a comparable process engineering/technical services role.
    • Must have experience working in a sterile manufacturing environment.
    • Ophthalmic manufacturing experience a plus.
    • Experience with many of the following processes:
      • Vial or bottle filling of sterile solutions
      • Compounding – dispensing, formulation, sterile filtration, etc.
      • Isolator technology incl. VHP
      • Cycle time and yield improvement initiatives
      • Continuous improvement projects
      • Regulatory audit preparation and follow-up
      • Cleaning (CIP/SIP) and sterilisation technologies
      • Component preparation – autoclaves and parts washers.
      • Primary container closure components
    • Specific knowledge of sterile pharmaceutical manufacturing processes and technologies. Ideally, aseptic filling operations.
    • Strong technical knowledge of aseptic manufacturing techniques, procedures and theory.
    • Strong analytical skills, documentation skills and research skills.
    • Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
    • Strong understanding of pharmaceutical industry regulatory requirements.
    • Clear understanding of the needs of cGMP and validation (DQ-PQ).
    • DoE knowledge desirable.
    • Knowledge of sterilization principles and practices
    • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently
    • Can operate with low levels of supervision
    • Strong team player, with a good proactive approach & manner

     

    To Apply:

     

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

    14 Danville Business Park, Kilkenny, Ireland
    +353 56 77 90100
    recruitment@prochem.ie

    Click here to submit your CV

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