Process Development Engineer – Co. Wicklow

Role Purpose:

• Our client has an immediate vacancy for a Process Development Engineer to support their Manufacturing Sciences Department during a busy period of NPI/ Tech transfer projects on their site in Co. Wicklow.
• The department is responsible for Tech transfers of new products as well as supporting and improving existing processes in a pharmaceutical plant operating to HPRA and FDA standards.
• Hybrid working; depending on training and project activity some weeks will be 100% site based and some weeks ~50:50.

Core Duties and Responsibilities:

• Provide a new product introduction and process development service to manufacturing operations in Processing, Tabletting and Packaging.
• Introduction of new products, materials and technologies; the discovery of process improvement opportunities and the re-development of legacy processes to increase productivity, reduce manufacturing costs and eliminate quality defects.
• Lead projects including technical transfers and post approval product lifecycle change management. Lead and execute early-stage feasibility, technical, process optimisation and process validation studies.
• Specific ongoing and upcoming projects include:
  • Multiple new drug product introduction on new process equipment
  • Strategic products hypercare and process support
  • Roll-out of new digital tools: Discoverant for CPV and KNEAT for paperless validation
• There are other projects and initiatives in the planning stage and the Process Development Engineer is expected to be flexible with regard to project assignment.
• The candidate is expected to liaise with local site and global company SMEs regarding best technical solutions, change management, production and quality system readiness and project implementation strategy.

Education & Qualifications Required:

• Degree in Science/ Engineering required, ideally a Masters.
• Minimum of 3 years experience as a Process Engineer.
• Extensive experience in the pharmaceutical sector required.
• Excellent project management skills with the ability to manage multiple projects simultaneously required.
• Experience in Tech Transfer and Process Validation desirable.
• Experience with Veeva, SAP, Pilot Lab and Digital CPV Program would be an advantage.
• The candidate should have a good understanding and experience of the following key areas:
  • Feasibility / Project plan / Stakeholder engagement
  • Project team set up / cross functional communication / chairing & recording meetings
  • Project reporting and Schedule management
  • GMP change management and risk assessment
  • Cross-functional team leading
  • Trial and process validation study execution
  • Doc authoring for Regulatory submissions
  • Completion / training / handover
  • Operations, process / technical support / Hypercare

To Apply: Quote – PE23070

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, R95 F727, Ireland.
+353 56 77 90100
recruitment@prochem.ie

Click here to submit your CV

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