Job Description
We are seeking a Process Engineer – Upstream to support upstream biologics manufacturing operations within a GMP-regulated biopharmaceutical manufacturing environment. The role will focus on upstream process operations including bioreactor, fermentation, preculture, and centrifuge support activities across manufacturing operations.
Key Responsibilities
Support day-to-day upstream manufacturing operations within biologics production environments.
Perform operational support activities for bioreactor, fermentation, preculture, and centrifuge processes.
Monitor process performance and support troubleshooting activities during manufacturing operations.
Support batch execution and ensure adherence to GMP procedures and manufacturing requirements.
Coordinate with Manufacturing, MSAT, Engineering, Validation, and Quality teams to support process reliability and operational readiness.
Assist with deviation investigations, CAPA activities, and change control support where required.
Support equipment setup, preparation, and operational checks for upstream processing activities.
Ensure manufacturing documentation is completed accurately and in compliance with GMP requirements.
Participate in continuous improvement and operational efficiency initiatives.
Requirements
Degree or Diploma in Biotechnology, Chemical Engineering, Bioprocess Engineering, Life Sciences, or related discipline.
Minimum 3 years of experience within upstream biologics or biopharmaceutical manufacturing environments.
Hands-on experience supporting:
Bioreactor operations
Fermentation processes
Preculture activities
Centrifuge operations
Experience working within GMP-regulated biopharma manufacturing environments.
Exposure to manufacturing operations support within upstream processing areas.
- Ability to work effectively within cross-functional manufacturing teams.