• Cork

Initial 12-month contract. Days, onsite role.

Description:

Manufacturing Process Specialist (BU3 – Purification). Reporting to the Operations Manager, this position is responsible for first line troubleshooting of the day-to-day activities within manufacturing.

You will be working within downstream manufacturing for a new start up 15,000 litre scale fed-batch facility – A mixture of commercial and clinical products for therapeutic areas.
Initially the role will involve 10 weeks of being on the manufacturing floor full time to build relationships and competency in the area. After this the successful candidate will be moved to a core team member role for an exciting introduction of a new product to the suite.Working with process scientists, project engineers, automation engineers etc. to ensure the successful transfer of a new product to area ensuring all operational requirements are met.

General Activities/ Manufacturing 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 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.
  • Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
  • Chromatography steps
  • Virus Inactivation and POD filtration
  • UFDF and Final Fill operations
  • Troubleshooting of downstream processing
  • 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.
  • Support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities.
  • Support ongoing studies by Validation, OTS and other support functions.
  • Be familiar with daily activities in operations

 QUALIFICATIONS AND EXPERIENCE

  • A relevant level 8 or higher qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering.
  • Minimum of 1yrs relevant experience in a similar environment.

Desirable

  • Postgraduate Qualification desirable but not required.
  • Bio-pharmaceutical Manufacturing experience desirable.
  • Experience executing GMP change controls and investigating quality issues desirable.
  • Experience of Purification either in a manufacturing or a lab-based environment.
  • Experience of DCS (e.g., Delta V)
  • Experience on MES, PasX Werum or similar
  • 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.

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