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