Indianapolis $100,000 - $130,000 Permanent
Develop, implement, and optimize manufacturing processes for drug substance or drug product operations.
Provide technical support for production activities, including troubleshooting process and equipment issues.
Author and revise batch records, SOPs, process descriptions, and change controls.
Support root cause investigations and implement corrective and preventive actions (CAPAs).
Partner with validation, automation, and maintenance teams on equipment qualification, process validation, and tech transfers.
Monitor and analyze process data to identify trends, drive continuous improvement, and improve yields.
Participate in scale-up and new product introduction projects.
Ensure all operations comply with GMP, safety, and regulatory requirements.
Bachelor’s degree in Chemical, Biochemical, Mechanical, or Process Engineering (or related field).
3–7 years of process engineering experience in a pharmaceutical, biotech, or CDMO environment.
Solid understanding of GMP manufacturing principles and process documentation.
Experience with bioreactors, filtration systems, CIP/SIP skids, mixing, or filling equipment.
Familiarity with process control systems (e.g., PLC, SCADA, or DeltaV).
Strong problem-solving, data analysis, and technical writing skills.
Excellent cross-functional communication and teamwork abilities.
Lean Six Sigma or continuous improvement experience is a plus.
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