• 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
  • Lead Manufacturing Biotech Associate – Co. Meath

    Role Summary


    • We are looking for a Lead Manufacturing Biotech Associate to join our client’s new state of the art biopharmaceutical facility in Co. Meath. This role will be part of a Manufacturing Self Directed work team/ Hub.
    • The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
    • The Lead Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and collaboration skills.
    • The successful candidate is responsible for supporting the manufacturing process, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset.
    • Ensure that objectives are effectively achieved, consistent with site requirements to ensure compliance, safety and provide a reliable supply to customers.
    • This role is a site-based position.
    • This role will involve working shift, on a 24/7 basis.


    Core Duties and Responsibilities:


    • Carry out and support operations to achieve assigned duties.
    • Deliver shift standard work for a team-based approach to batch progression.
    • Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.
    • Conduct sampling/ in-process testing supporting the manufacturing and validation processes.
    • Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT).
    • Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance with cGMP requirements.
    • Provide coaching to the shift teams on the RFT approach to documentation.
    • Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.
    • Initiate/ maintain housekeeping in all work areas.
    • Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate.
    • Support execution of safety walkdowns, audits/ inspections, risk assessment, implementation of agreed upon actions, etc.
    • Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as and when required.
    • Coach and provide oversight on the shop floor to identify potential issues before they arise.
    • Actively participate on cross-functional manufacturing teams to advance projects, goals and deliverables.
    • Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
    • Lead straight-through document accuracy metrics and the development of a CI framework.
    • Support site functional initiatives to improve compliance status and operational efficiency of the site.
    • Run handover boards and provide key updates to shift leads for handover.
    • Be escalation point of contact (POC) for troubleshooting, supporting task execution, problem solving,
    • CI projects and assist with the resolution of issues/ delays.
    • Take ownership of activities within a suite and act as a delegate for the shift lead if they are unavailable.
    • Ensure process equipment is maintained including preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of equipment.
    • Effectively manage and schedule equipment shutdowns.
    • Ensure resources are available, thereby minimizing downtime.
    • Any other duties as and when assigned by the Manager.


    Minimum Qualifications and Experience:


    • Minimum of a Bachelors Level 8 degree in Science, Engineering or other Technical Discipline.
    • 5 years experience in a GMP environment.
    • 3 years experience in Biopharma industry, with direct experience of biologics manufacture.
    • Proven record of accomplishments in a regulated industry required
    • Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of Good Manufacturing Practices.
    • Ability to effectively coach new trainees to build their skills so that they may become effective operations technicians and subject matter experts.
    • Ability to think logically and be proactive under pressure.
    • Excellent trouble shooting and problem-solving skills to coach and mentor the teams through complex problems solving.
    • On-the-floor current Good Manufacturing Practice (cGMP) manufacturing and familiarity with regulatory requirements.
    • Proficiency with automated systems such as Manufacturing Execution System (MES – PAS X),
    • Systems Applications and Products (SAP), Delta V etc.
    • Knowledge of Lean methodologies.
    • Familiar with all Safety, GMP, Environmental and Validation permits, policies and procedures.
    • Familiar with plant equipment.
    • Training others and/ or leading hands-on or instructor-led training.
    • Ability to read, write and understand technical information.


    To Apply: Quote – PE22108


    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

    Click here to submit your CV

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