• Cork

R.T. Lane Recruitment

€28~€35 PH. Initial 18-month contract role.

POSITION SUMMARY

Reporting to the Operations Manager, this position is responsible for supporting the expansion of our current large scale fed batch facility within manufacturing. These activities include but are not confined to the following:

General Activities

  • Monitoring and troubleshooting of the commercial and clinical manufacturing processes and process optimization.
  • Monitoring and reporting of process performance using statistical process control.
  • Generation of data and reports to support Annual Product Reviews and Regulatory submissions.
  • Troubleshooting of process specific equipment.
  • Troubleshooting of DCS (e.g. Delta V) and PLC control systems.
  • Investigating and resolving Deviations raised within the Manufacturing Department.
  • Participate in/ Lead Cross Functional teams when required.
  • Support of Commissioning and Qualification activities.
  • Preparation and updating of Batch Records, Procedures and Work Instructions.
  • Provide process and equipment related training as required within the Manufacturing Department.
  • Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
  • Working assigned days or shift patterns to meet business needs and manufacturing schedule.

GENERAL SCOPE OF RESPONSIBILITIES:

  • Lead by example and strive to perform to high standards at all times
  • Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behaviour in every activity.
  • Carry out routine and non-routine tasks delegated by the Team Lead according to appropriate procedures, values and standards.
  • Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
  • Compliance with Manufacturing and general site procedures at all times.
  • Completion of all documentation in compliance with site procedures and GDP.
  • Execution of activities as necessary to meet operational and business needs.
  • Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities.
  • Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.
  • Lead and Support investigation and resolution of problems on plant.
  • Participate in and lead Cross-Functional teams as necessary.
  • Generate and assist with generation, review and revision of Manufacturing documentation as necessary.
  • Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Manufacturing group.
  • Support ongoing studies by Validation, OTS and other support functions.

QUALIFICATIONS AND EXPERIENCE

ESSENTIAL

  • A relevant third level 8 qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering.
  • Manufacturing experience within a GMP regulated environment.
  • Experience of Buffer or Media preparation or Equipment preparation in a manufacturing environment.
  • Experience of Cell Culture either in a manufacturing or a lab-based environment.
  • Experience of DCS (e.g., Delta V), SCADA and PLC systems.
  • Experience of SAP, LIM’s and/or other business systems.
  • 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.

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