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Process Development Engineer & Similar Roles

Job description

Working with several clients across Dublin and Ireland - which are looking for Process Engineers, Process Support Engineers, Process Development Engineers within both, Pharmaceutical and Biopharmaceutical GMP facilities.

Process Support Engineer

  • Lead key areas of process improvement projects to improve equipment availability and production efficiency – “continuous improvement programme”.
  • Assist with project work connected with installation, validation, and commissioning of new and existing process equipment and automation control systems.
  • Assist with monitoring and control of process equipment and general facilities with regard to maintaining a constant, safe and reliable operation.
  • Work with the Production Department to provide adequate support during process investigations and CAPA implementation.
  • Maintain effective document control systems for the Process Support Group.
  • Actively embrace the culture of teamwork and integration within the Engineering Department, and most importantly with both Production and QA Departments.

Process Development Engineer

  • Lead a team of NPI projects in accordance with a pre-approved project plan, schedule and current project management best practice. Ensure that critical manufacturing systems and support structures are in place for major technology transfer and NPI projects and provide technical advice on process engineering requirements as needed. 
  • Execute early stage feasibility, technical, process optimisation and process validation studies.
  • Liaise with the Technical Services Process Support Team to identify process improvement opportunities for legacy products. Propose and implement sustainable solutions to reduce processing times, improve yield, reduce defects and eliminate waste.
  • Identify cost-effective opportunities for the introduction of best-in-class manufacturing technologies. Design and introduce these technologies to manufacturing operations.
  • Input into the Technical Services management systems including strategic project planning.
  • Review of Change Records and Risk Assessments to assess process impact and validation status as required.
  • Provide regular progress updates (written and verbal) on projects and activities within and beyond Process Development Group as stated in project communication plans and/or as required by the relevant stakeholders.
  • Manage the workload and resource plans of direct and indirect reports while supporting individual learning and development objectives through coaching and mentoring.
  • Comply with the relevant industry and Company quality standards and the cGMP rules pertaining to production.

Senior Process Engineer

This is an exciting opportunity, with an initial offering of either contract or temporary placement - with a view to permanency subsequent to finishing an initial placement period. You would ideally be very experienced particularly within the packaging side of syringe and vial sterile manufacturing.

Job Daily Tasks:

  • Oversee packaging activities with respect to New Product Introductions
  • Serve as process development packaging subject matter expert.
  • Troubleshooting Final product technologies.
  • Participate and lead investigations with a view to investigating deviations and raising CAPA actions.
  • Develop IOQs and PQs
  • Oversee design transfer.
  • Ensure that all activities adhere to GMP, FDA and EMEA standards.
  • Participate in development and review of process validation, process characterization, process qualification and quality based documentation.
  • Act as site representative within the companies global process development team.

Job Essentials

  • GMP Experience
  • Experience in medical devices, pharmaceutical, or biopharmaceutical based similar roles.
  • Experience of Process Characterisation, Technical Transfers and Validation activities.
  • Working knowledge of quality systems, and the processes associated with packaging of Drug Final Product and associated Validation activities.

Contact

If you are interested in this role(s) apply below. I also have more senior or indeed junior roles within QC, QA, QP, Validation, CQV, PM and other areas of pharmaceutical, medical device, and biologics companies. Send me an email or simply your CV to schedule a confidential chat (014744692) - to andrius "at" sigmar.ie

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