The Manufacturing team is expanding and seeking an Associate Engineer, Manufacturing – Upstream (Process) to support routine upstream biopharmaceutical manufacturing operations, with a focus on process robustness.
The Associate Engineer, Manufacturing – Upstream (Process) supports day‑to‑day upstream manufacturing operations by ensuring that upstream processes (e.g, seed train, cell culture, bioreactor operations, multi-column chromatography, viral inactivation) are executed consistently, within defined process parameters, and in compliance with GMP requirements.
The role operates within a defined process scope and supports Manufacturing Operations by monitoring process performance, analyzing trends, supporting investigations, and contributing to continuous improvement of upstream process robustness.
As required, the role may support New Product Introduction (NPI), process startup, and validation activities, primarily from an execution, monitoring, and documentation standpoint.
This position reports to the Senior Manager, Manufacturing and works closely with cross‑functional teams.
Key Responsibilities
1. Routine Manufacturing & Asset Care Support (Primary Focus)
Support routine upstream manufacturing operations within assigned scope.
Monitor critical process parameters, trends, and process performance indicators to ensure operations remain within defined control limits.
Identify process deviations, abnormalities, or drift; document observations and escalate issues in a timely manner.
Provide day‑to‑day technical support to Manufacturing Operations related to upstream process execution.
Act as operational process SME for assigned upstream unit operations, supporting safe, compliant, and consistent process performance.
Support updates to upstream SOPs, batch records, and process documentation related to new or modified processes.
2. Upstream Process Robustness & Performance
Support routine review and trending of upstream process data to identify variability, recurring issues, or opportunities for improvement.
Support implementation of process improvements aimed at enhancing robustness, yield, consistency, or operational reliability.
Collaborate with MSAT and Automation teams to support effective use of digital tools and process data
3. Support to New Product Introduction (NPI) & Startup (Limited Scope)
Support NPI and process startup activities as assigned, such as:
Execution support during engineering runs, PPQ, or startup manufacturing
Process data collection, verification, and documentation
Support of process readiness and operational handover activities
Participate in upstream process risk assessments (e.g. FMEA) by gathering information and supporting action tracking.
Support updates to upstream SOPs, batch records, and process documentation related to new or modified processes.
4. Deviation, Investigation & CAPA Support
Participate in process related deviations and investigations
Escalate complex issues to Senior Engineers in a timely manner.
5. GMP, Safety & Compliance
Perform assigned activities in compliance with GMP, EHS, and site requirements.
Support audit and inspection readiness through accurate and timely documentation.
6. Continuous Improvement
Identify and propose improvement opportunities related to upstream process robustness, control, or execution.
Participate in OE / Lean / continuous improvement initiatives focused on upstream manufacturing processes.
Knowledge, Skills & Competencies
Basic understanding of upstream biopharmaceutical processes (e.g. seed train, cell culture, bioreactor operations, multi-column chromatography, viral inactivation).
Working knowledge of GMP requirements and process data integrity principles.
Basic data analysis and trending capability to support process performance monitoring.
Able to work effectively within cross‑functional teams with appropriate guidance.
Demonstrates structured problem‑solving and analytical thinking.
Good technical writing and communication skills.
Strong team player with a continuous learning mindset.
Qualifications / Requirement
Diploma or Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or related discipline.
3–4 years of experience in upstream biopharmaceutical manufacturing, process support, or manufacturing operations in a regulated environment.
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