Technical Operations Engineer (On-site)
Core
Tech Ops Engineer supporting FLEx Non-Sterile clinical manufacturing operations, ensuring equipment readiness, troubleshooting, and compliance for safe delivery of clinical supplies.
Role type
hands-on manufacturing engineer (clinical supplies)
Builds
clinical supplies via non-sterile manufacturing
Domain
pharmaceutical/biotechnology manufacturing
Deliverable
production features
Required skills
equipment ownership, troubleshooting, GMP compliance, root cause analysis, capital project support, digital manufacturing systems, standard work development, batch execution support, change control, vendor coordination
Preferred skills
oral solid dosage processes, automation troubleshooting, Lean/Six Sigma, data analytics platforms, validation/commissioning experience
Technologies
PAS-X, SAP, PI/historian systems, Power BI, electronic batch records
Responsibilities
maintain equipment readiness and technical references, lead troubleshooting and deviation investigations, support batch execution and campaign readiness, coordinate capital projects and equipment upgrades, author and review GMP documentation, coach operators and engineers on compliant execution
Seniority
Mid-level, hands-on IC