Associate Process Engineer, Technical Operations - Small Molecule Drug Substance
Core
Provide technical support for facility design, commissioning, qualification, technology transfer, and ongoing commercial manufacture of active pharmaceutical ingredients (APIs) in a small molecule drug substance facility.
Role type
Associate Process Engineer, Technical Operations
Builds
Active pharmaceutical ingredients (APIs) for patients in the U.S.
Domain
Biopharmaceuticals / Small molecule manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Chemical or Process Engineering fundamentals, API processing unit operations, Manufacturing scale-up, cGMP manufacturing understanding, Process support or development, Technology transfer, Manufacturing operations, Deviation investigations, Root cause analysis, Batch record generation, Process optimization, Data analysis, Technical problem solving
Preferred skills
None explicitly stated beyond current employee/contingent worker status
Technologies
None explicitly stated
Responsibilities
Support capital project design, commissioning, and startup readiness; Take ownership of assigned process equipment and manufacturing processes; Support technology transfer and validation activities (pre-PPQ, PPQ); Analyse process data to support performance monitoring and troubleshooting; Provide on-the-floor technical support during manufacturing campaigns; Identify and implement improvements in process robustness and plant performance; Assist in deviation investigations and CAPA implementation; Ensure compliance with cGMP, safety, and environmental standards.
Seniority
Associate, 1–4 years experience
