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Search Results for Process Development Engineer
Job Title. Location Salary Actions

Biologics Snr PM contractor

Our client is a multinational biologics processing facility in south Dublin. It’s a 12 month contractor assignment that will pay up to €63 per hou

Location: Dublin South,
Biologics Snr PM contractor
Dublin South Not Disclosed

Process Scientist

Process Scientist Our client based in Tullamore is operating a 20,000 square foot facility which will focus on the manufacture of biopharmaceutical drug subs

Location: Offaly,
Process Scientist
Offaly Not Disclosed

Senior Process Engineer

Our client is multinationl pharma company which produces finished products in its Dublin facility. They are seeking a skilled Snr Process Engineer to join thei

Location: Dublin North,
Senior Process Engineer
Dublin North Not Disclosed

Senior Process Development Scientist

Our client is a multi-national pharmaceutical organisation who have multiple sites in Ireland. This role is based in their diverse Corporate office based in North Dublin. Previous experience is Oral Solid Dose Process Development is essential for this exciting and diverse role. Responsibilities: - You will lead and coordinate process improvement strategies for existing formulations and provide technical support as required to the Manufacturing Department. - Responsible for coordinating projects such as Scale-ups, Second sourcing, New Equipm...

Location: Dublin North,
Senior Process Development Scientist
Dublin North €65000 - €70000
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Quality, Compliance and Regulatory Affairs Coordinator Dublin Not Disclosed
Quality Assurance Systems Manager Remote Working Opportunity Dublin Not Disclosed
R&D Project Manager Galway Not Disclosed
Equipment Process Engineer (Lyo - Aseptic Sterile Fill Finish) Sligo Not Disclosed

Process Development Engineer Career Profile

Process Development Engineer

A Process Development Engineer or New Product Introduction Engineers is charged with taking a concept or a prototype from small scale into full scale commercialisation. Process Development Engineers require a strong project management background as the role is cross functional and requires interaction with many different groups, R&D, Quality, Manufacturing, Reg Affairs etc Very often role will require international travel as R&D facility may be located in a different country to manufacturing facility

Typically the Process Development Engineer will have a degree in Engineering and 2-3 years experience in scales up, tech transfers and commercialisation projects. Good communication skills are essential.

Key Responsibilities of the Process Development Engineer

  • Co-ordinating all activities to design, develop and introduce to production new products in accordance with the requirements of ISO 13485:2003 & latest Medical Device Directive & other standards that may apply.
  • Co-ordinating the generation of Design Files, Technical Files and Project Files to include Design Objectives, Design Reviews, Design Outputs, Design Verifications, Shelf Life studies, Bio-compatibility, Sterilisation, Risk Analysis, Validation Master Plans, IQ's, OQ's, PQ's, Test regimes etc., as required for new products and significant changes in existing products.
  • Co-ordinating the activities required to develop new products and processes.
  • Co-ordinating the acquisition of new materials required for new products
  • Co-ordinating the acquisition of new equipment and tooling required for new products, including test and measurement equipment.
  • Supporting the Business Acquisition process in providing technical support, drawings/specifications, samples, costing data and other information that may be required to generate new business.
  • Supporting the production department, especially with regard to new products, with regard to process issues, CAPA's, Engineering Changes, Customer complaints etc as and when required.
  • Ensuring all activities are carried out according to the relevant Medical and Industry standards and internal procedures.
  • Provide accurate and up-to-date reporting on projects

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