What are the responsibilities and job description for the Process Development Engineer position at United Pharma?
About the job:
We are seeking a Process Development Engineer to support manufacturing development, validation, and process optimization activities for Class III medical devices. This role will work closely with QA, R&D, and Production teams to improve manufacturing processes and support new technology integration.
Responsibilities:
• Lead process development, characterization & optimization activities
• Support IQ/OQ/PQ, TMV & risk management activities
• Develop validation protocols and manufacturing documentation
• Support automation and fixture improvements to reduce manual processes
• Ensure compliance with GMP & ISO 13485 requirements
• Collaborate with cross-functional teams to support process scale-up and production readiness
Qualifications:
• 5–8 years of Process Development or Manufacturing Engineering experience
• Medical device industry experience (Class III preferred)
• Strong validation & process characterization background
• Experience with IQ/OQ/PQ, TMV & process documentation
• Knowledge of GMP & ISO 13485 standards
• Strong troubleshooting and communication skills