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 looking to hire a Process Scientist for our client based in Sligo.
Responsibilities: Performing gap analysis, facility fit studies, process safety and risk analysis for NPI.
Monitoring and analysis of process data during the manufacturing.
Assisting in the development of the manufacturing process for new products.
Providing operational technical support for process related issue resolution.
Preparation and updating of specifications related to NPI materials and consumables.
Lead and / or assist risk assessments (e.g., PFMEA, EHS).
Development of NPI related documents e.g., Transfer Plans/Protocols/Procedures/Manufacturing Batch Records.
Working closely with global science and quality teams, on the process development of suitable future products Assisting and /or leading product and process related investigation and change plans.
Supporting, supervising, and training operations personnel for NPI processes Adheres to and supports all EHS&E standards, procedures, and policies.
Requirements: Essential Requirements Third level degree in a relevant engineering, science or technical discipline required.
Desired Requirements Masters Qualification in relevant technical discipline desirable.
3 years' experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale up, in a cGMP pharmaceutical or Biologics industry.
Experience in new product introductions to Biologic facilities desirable.
Top Desired Skills: Knowledge of Single-Use Technologies: Understanding single-use systems such as bioreactors, mixing systems, tubing, and connectors used in biopharmaceutical processes.
Experience in design of single use assemblies for new projects GMP Compliance and Documentation: Experience working in a Good Manufacturing Practice (GMP) environment, including proper documentation, batch records, and adherence to quality and regulatory standards.
Equipment Setup and Troubleshooting: Hands-on skills for setting up, operating, and troubleshooting single-use equipment and related process systems.
Communication and Teamwork: Effective communication skills to interact with cross-functional teams and the ability to train or mentor others in single-use system operations.
Previous experience in ADC manufacturing facilities Previous experience process transfer in GMP manufacturing facilities Experience in cleaning study design Experience in upstream processing, UFDF, mixing, single use, chromatography Working in team exposure and capacity to influence decision making To start the process click the Continue to Application or Login/Register to apply button below.