Key skills
Pharmaceutical manufacturing processescGMPFDA regulationsProcess validationIQ/OQ/PQCorrective and Preventive Actions (CAPA)Lean Six Sigma methodologiesReactorsBioreactorsFiltration systemsLyophilizersData analysis toolsProcess monitoring systemsAutomation systemsDeltaVPLCSCADATechnology transferScale-upRCommunication
About this role
JVM Global Inc is seeking a highly motivated Process Engineer to join their growing pharmaceutical manufacturing team in the United States. This role is critical in optimizing production processes, ensuring regulatory compliance, and driving continuous improvement initiatives across operations.
Responsibilities:
- Design, develop, and optimize pharmaceutical manufacturing processes (API and/or drug product)
- Ensure compliance with cGMP , FDA , and other regulatory standards
- Lead process validation activities including IQ/OQ/PQ
- Troubleshoot process deviations, identify root causes, and implement corrective actions (CAPA)
- Collaborate with cross-functional teams (Quality, R&D, Manufacturing)
- Support technology transfer and scale-up activities
- Drive continuous improvement using Lean/Six Sigma methodologies
- Prepare and maintain technical documentation (SOPs, batch records, validation protocols)
Requirements:
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or related field
- 2–8+ years of experience in pharmaceutical or biotech manufacturing
- Strong knowledge of GMP regulations, process validation, and regulatory requirements
- Experience with equipment such as reactors, bioreactors, filtration systems, or lyophilizers
- Familiarity with data analysis tools and process monitoring systems
- Excellent problem-solving and communication skills
- Experience with biologics, sterile manufacturing, or solid oral dosage forms
- Lean Six Sigma certification (Green Belt or higher)
- Knowledge of automation systems (DeltaV, PLC, SCADA)
- Experience in tech transfer and scale-up