Process Engineer – FDA Remediation (Drug / Combination Products)

Job Title: Process Engineer – FDA Remediation (Drug / Combination Products)Job Type: Contract (W2) 12 monthsShift / Hours: Day shift, standard business hours with flexibility for floor supportPay Range: $50-$60/ hrOverviewA large life sciences manufacturing organization is seeking a Process Engineer to support a high‑priority FDA remediation initiative for a legacy drug–device combination product. This role is highly onsite and hands‑on, requiring deep manufacturing floor engagement and independent ownership of process assessment, documentation remediation, and validation execution. The environment has limited internal process engineering infrastructure, making this a critical individual‑contributor role with high visibility.Key ResponsibilitiesLead end‑to‑end assessment of manufacturing processes currently under FDA scrutinyPerform detailed process mapping to compare actual shop‑floor operations against documented proceduresConduct comprehensive gap assessments across manufacturing processes, SOPs, and supporting documentationAuthor and remediate:Manufacturing SOPs and work instructionsProcess documentation, forms, and recordsUpdated process flow diagramsLead process validation activities aligned with FDA’s 3‑stage lifecycle model, including required re‑validationsBuild and implement a sustainable framework for:Process characterizationValidation strategyContinuous Process Verification (CPV)Partner directly with manufacturing operators, supervisors, and site leadership to ensure practical, compliant processesSupport FDA inspections and remediation activities by ensuring documentation, FMEAs, and validation materials are inspection‑readyRequired Skills & Experience5+ years of Process Engineering experience in an FDA‑regulated manufacturing environmentStrong drug cGMP expertise with working knowledge of 21 CFR Part 211Drug manufacturing experience required (device‑only backgrounds will not be considered)Working knowledge of 21 CFR Part 4 (combination products)Experience with FDA Process Validation GuidanceProven ability to work onsite, hands‑on, and independently in manufacturing environmentsExperience engaging directly with operators and owning remediation efforts end to endPlussesPrior FDA remediation or inspection response experienceCombination product manufacturing backgroundHands‑on leadership of process validation execution