RCI-SNFI-9722 Process Engineer

Join a global biotech leader as a Process/Packaging Engineer supporting manufacturing and packaging operations. You’ll work on cutting-edge formulations, lead technical documentation, and support cross-functional teams across the US, Canada, and Europe. This role is based onsite in NJ

Key Responsibilities

• Write and manage technical reports, SOPs, and protocols
• Support MSAT-US with pharma packaging and process optimization
• Lead or support equipment and process qualifications (IOQ/PPQ)
• Evaluate packaging materials and processes for regulatory compliance
• Collaborate with R&D, QA, Regulatory, and external CMOs
• Drive project timelines, risk mitigation, and manufacturing readiness
• Provide packaging recommendations aligned with FDA/EMA standards

Must-Have Skills

• Degree in Process or Packaging Engineering (BS/MS/PhD accepted)
• 5 years in pharma/biotech process engineering
• Experience with FDA & EMA regulations
• Strong technical writing and project management skills
• Hands-on with liquid formulation processes
• Experience with equipment start-up, qualification, and validation

Nice to Have

• Packaging standards knowledge: USP, ASTM, ISTA, IATA, CFR
• Familiarity with CMC, Tech Transfers, and commercial launches

You can Also apply here: https://careers.rangam.com/jobs/jobdetails/125186