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Senior Process Validation Engineer

Pharma & Life Sciences, Pharmaceuticals, Biopharmaceuticals / Biologics
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This vacancy has now expired.


Reporting to the Engineering Manager, this process engineering role is responsible for the control, optimisation and development of existing processes through short and long term projects. Responsibilities include the introduction of new products or processes into the site as required.


  • Develop in-depth knowledge of Chromatography Manufacturing Plant.
  • Continuous improvement of the critical chemical processes including SCADA and setup appropriate process control measures to track these.
  • Recommend / design appropriate trial activities in association with production, R&D and quality to reduce cycle time, increase yield, improve safety and product quality. Ensure all trial activities are clearly documented.
  • New raw material characterisation / validation.
  • Analyse and implement corrections to technical issues relating to production processes, ensuring the process works at the optimum level, to the right rate and quality of output, in order to meet supply needs.
  • Support the management of the plant BOMs & Routings, Change Control, develop expertise in Oracle and SAP.
  • Support EHS Compliance & Facility Upgrade Projects.
  • Develop and sustain an environment of continuous improvement through active implementation of Process Excellence and Lean Six Sigma methodologies.
  • Ensure all process related documentation is audit & inspection ready. Ensure compliance in accordance with cGMP and safety rules on new and existing equipment.

Experience required:

3rd level degree in Process/Chemical/Manufacturing engineering

5-10 years within an API or Biotechnology within a chemical processing environment.

Knowledge of Chromatography an advantage.

Berkley Engineering is a specialist recruitment consultancy which recruits pharmaceutical, medical device and clinical professionals throughout Ireland, Europe, Asia and Australia.

For more information and to see all the Engineering Jobs available go to

To apply: If you would like to discuss this vacancy further or to discuss your career and other job options in confidence, please telephone Heather Haitse on +353 (0)21 4289616 or send your CV to

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