Process Engineer

3 weeks ago

Sligo, Ireland Gertek Project Management Full time

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. We are seeking a process engineer to join our life science manufacturing project in Sligo. Responsibilities: 1. Performing gap analysis, facility fit studies, process safety and risk analysis for NPI. 2. Monitoring and analysis of process data during the manufacturing. 3. Assisting in the development of the manufacturing process for new products. 4. Providing operational technical support for process related issue resolution. 5. Preparation and updating of specifications related to NPI materials and consumables. 6. Lead and / or assist risk assessments (e.g., PFMEA, EHS). 7. Development of NPI related documents e.g., Transfer Plans/Protocols/Procedures/Manufacturing Batch Records. 8. Working closely with global science and quality teams, on the process development of suitable future products for the company. 9. Assisting and /or leading product and process related investigation and change plans. 10. Supporting, supervising, and training operations personnel for NPI processes 11. Adheres to and supports all EHS&E standards, procedures, and policies. Requirements: Essential Requirements 1. Third level degree in a relevant engineering, science or technical discipline required. Desired Requirements 1. Masters Qualification in relevant technical discipline desirable. 2. 3 years' experience in pharmaceutical process engineering, with relevant experience of batch 3. processing, technical transfers, scale up, in a cGMP pharmaceutical or Biologics industry. 4. Experience in new product introductions to Biologic facilities desirable. Top Desired Skills: 1. Previous experience with DP fill finish for Biologics product 2. Previous experience with LYO products 3. Previous experience with technical transfer projects and deliverable (gap assessment, cleaning assessment, etc.) 4. Familiarity with DP processes developed with single use design To start the process click the Continue to Application or Login/Register to apply button below.

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