Process Engineer/Upstream Biotechnologist- New Product Introduction/Brownfield Project-BioPharma

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients.

This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.

We are currently looking for Upstream Biotechnologist/Process Engineer to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry.

Key Responsibilities

• Act as Process Owner for Single-Use System (SUS) activities and support routine biologics manufacturing operations.
• Troubleshoot single-use defects, process issues and decontamination-related activities.
• Support deviation investigations, root cause analysis and CAPA implementation.
• Must have upstream process knowledge including but not limited to Harvesting, inoculation, centrifuge systems, fermentation systems etc.
• Have worked on large NPIs/Brownfield projects.
• Prioritize assigned tasks and ensure all work is documented according to approved manufacturing formulas.
• Troubleshoot and resolve equipment and process issues.
• Operate computers for process control and data entry (using systems such as Delta-V and SAP).
• Create documentation like SOPs, MBRs and process design maps.
• Ensure assemblies are properly welded using the Bio Welder and verify connections.
• Conduct pressure tests, leak tests, and helium tests to prevent vessel leaks and ensure vessels are in optimal condition for subsequent processes.
• Use the SAP system to transfer materials from other departments to the upstream department.
• Own/support change controls related to manufacturing processes, single-use systems and NPI activities.
• Provide technical and shop-floor support during manufacturing and new product introduction.
• Collaborate with Manufacturing, MSAT, Quality, Engineering and Validation teams.

If you'd like to find out about this opportunity or any other opportunity, please forward your CV to Nelson Anthony ([Confidential Information]).

If you would like to find out about the latest Jobs and Projects we are involved in then do follow us on LinkedIn: https://www.linkedin.com/company/processengineeringspecialists/mycompany/

PES International operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.