Job Description
Insight Global is seeking a Process Engineer to support a critical FDA remediation initiative for a legacy drug–device combination product at one of our life sciences clients. This role is onsite‑heavy and requires deep floor engagement to assess, correct, and formalize manufacturing processes currently under FDA scrutiny. The Process Engineer will act as an independent operator, leading end‑to‑end process assessment, documentation remediation, and validation execution in an environment with limited internal process engineering infrastructure. This Engineer will spend significant time on the manufacturing floor performing process mapping to compare actual operations vs. documented procedures, conduct detailed gap assessments across manufacturing processes, SOPs, and supporting documentation, author and remediate: Manufacturing SOPs and work instructions, Process documentation and forms, Updated process flow diagrams. They will lead process validation activities align...