Process Engineer

An amazing start-up engaged in the field of regenerative medicine is looking for the next process engineer to join their stellar team!

Responsibilities

• Lead the development and implementation of the upstream protein purification process: Process improvements and optimization, Process yields, and Scale ups
• Identify potential risks and mitigations
• Manage and investigate process-related discrepancies and propose related CAPA.
• Preparation of protocols, reports, change control documents.
• Implement New Technologies & Equipment - Initiate and lead introduction of new assets, equipment and systems that will contribute to the business strategic direction, in accordance with approved change control procedures.
• Equipment Qualification, Documentation & Change Control - Ensure that installations and changes to equipment and systems are carried out, qualified, and documented according to approved protocols, change control procedures and in compliance with relevant cGMP.
• Technology transfer from R&D to production including: Lyophilization process development and scale up Scale up of newly developed formulations Process validations (URS, VMP, protocols and reports)

Qualifications

• B.Sc. in biotechnology/ Chemical engineering/ other related Engineering fields with experience in biotechnology/pharma industries
• 5-8 years' experience in process engineering in pharma/Biotechnology/Food companies
• Demonstrated experience in protein purification with hands on experience in pilot scale downstream and/or upstream processes
• Deep understanding in Quality assurance, regulations and GMP practices and documentation