Process Engineer

JOB DESCRIPTIONInsight 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 aligned with FDA’s 3‑stage lifecycle model, including required re‑validations, Build and implement a sustainable framework for: Process characterization, Validation strategy, Continuous Process Verification (CPV). They will partner directly with operators, supervisors, and site leadership to ensure processes are practical, compliant, and inspection‑ready and support FDA interactions by ensuring documentation, FMEAs, and validation materials are inspection‑ready.REQUIRED SKILLS AND EXPERIENCE-5+ years of Process Engineering experience in an FDA‑regulated manufacturing environment, operating independently - Strong drug cGMP expertise (21 CFR Part 211) — drug experience required over device‑only backgrounds - Working knowledge of 21 CFR Part 4 (combination products) and FDA Process Validation Guidance - Proven ability to work onsite and hands‑on, engaging manufacturing operators and owning remediation work end to endNICE TO HAVE SKILLS AND EXPERIENCE- Prior FDA remediation or inspection response experience - Combination product manufacturing background - Hands‑on leadership of validation execution