Specialist, Process Engineering (Onsite)
Core
Lead the launch, regulatory certification, and operational readiness of a new sterile clinical drug product manufacturing facility, supporting complex formulation tech transfer and scale-up.
Role type
Specialist Sterile Process Engineer
Builds
GMP-compliant sterile clinical drug supplies for the pharmaceutical pipeline
Domain
Pharmaceutical manufacturing / Biologics and small molecule development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Chemical Engineering, GMP Compliance, Change Management, Standard Operating Procedure (SOP) Development, Quality Investigations, Process Simulation, Leadership, Process Development, Medicinal Chemistry, Medical Supply Management
Preferred skills
Aseptic Processing, Clinical Supply Chain Operations, Investigational Drug Regulatory Requirements, Sterile Technique, Business Readiness, Process Consulting, Project Commissioning
Technologies
GMP systems, Process Simulation tools, Quality Management Systems
Responsibilities
Lead facility startup and regulatory certification activities; Execute process tech transfer and scale-up for complex formulations; Author GMP standard operating procedures and protocols; Conduct quality investigations and manage process changes; Collaborate with formulation scientists and operations staff to ensure supply quality and process rigor.
Seniority
Specialist, hands-on IC with leadership responsibilities
