Process Engineer
Core
Design and implement complex manufacturing processes for oligonucleotide therapeutics in a GMP environment, leading projects from concept to structured results.
Role type
Senior IC Process Engineer (Biopharma Manufacturing)
Builds
GMP-compliant manufacturing processes, capital projects, and validation documentation for oligonucleotide therapeutics.
Domain
Biopharma / Pharmaceutical Manufacturing
Required skills
Process engineering (Upstream/Midstream/Downstream), GMP/CGMP compliance, Capital project management, Validation (IQ/OQ/PQ), Root cause analysis, Equipment sizing calculations, URS development, SOP creation, Process troubleshooting, Safety management (PHA/PSM)
Preferred skills
ASME BPE sanitary piping design, SCADA/PLC/BAS programming, Project management in biopharma, Industrial control systems validation, Data-driven process optimization
Technologies
SCADA, PLCs, BAS, ASME BPE, NFPA 70, ICH guidelines
Responsibilities
Provide engineering ownership for designated manufacturing process areas; Coordinate multi-disciplinary teams for project management; Collaborate on technical transfer and scale-up; Facilitate EHS activities and regulatory compliance (Change Controls, CAPAs); Support capital projects from design to commissioning; Drive continuous improvement initiatives; Perform process monitoring and optimization.
Seniority
Senior, hands-on IC
