Senior Specialist, Engineering (Onsite)
Core
Support routine operations and troubleshooting of sterile drug product manufacturing equipment to ensure compliant, high-quality clinical supply delivery.
Role type
Senior Specialist, Technical Operations Engineer
Builds
Sterile clinical supplies (small molecules, biologics, vaccines, ADCs)
Domain
Pharmaceutical manufacturing / Biotechnology / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Sterile processing equipment expertise, PLC/DCS/MES automation knowledge, Aseptic processing techniques, GMP compliance, Change management, SOP development, Technical troubleshooting, Project management, Process optimization, Root cause analysis, Six Sigma Green Belt
Preferred skills
Technical mentorship, Equipment commissioning and validation, ISA88/ISA95 principles, Clinical supply chain operations, Six Sigma Black Belt
Technologies
PLC, DCS, MES, Automated filling lines, Lyophilizers, Autoclaves, Isolators
Responsibilities
Troubleshoot and resolve production equipment issues, Establish new processes, Lead continuous improvement projects, Collaborate with cross-functional teams for compliant execution, Prepare SOPs and GXP documents, Train team members on procedures
Seniority
Senior, hands-on IC
