Associate Specialist, Technical Operations Engineer (On-site)
Core
Tech Ops Engineer supporting FLEx Non-Sterile clinical manufacturing operations, ensuring equipment ownership, production readiness, and troubleshooting for safe, compliant delivery of clinical supplies.
Role type
Associate Specialist, Technical Operations Engineer
Builds
Clinical supplies via FLEx Non-Sterile manufacturing operations
Domain
Biopharmaceutical manufacturing / Clinical supply chain
Required skills
Equipment ownership, Troubleshooting, Root cause analysis, GMP compliance, Change control, Capital project support, Standard work development, Data analysis, Cross-functional collaboration, Technical documentation
Preferred skills
GMP pharmaceutical manufacturing, Oral solid dosage processes, Automation troubleshooting, Lean/Six Sigma, Digital manufacturing systems (PAS-X, SAP, PI)
Technologies
PAS-X, SAP, PI/historian systems, Power BI
Responsibilities
Own manufacturing equipment trains and maintain technical readiness; Provide on-floor engineering support during campaigns and changeovers; Lead troubleshooting and deviation investigations; Author and review GMP documentation (SOPs, batch records); Support capital projects and equipment qualification; Coach operators and engineers on equipment and standard work.
Seniority
Associate Specialist, hands-on IC