Process Engineer - FDA Remediation (Drug / Combination Products)

Process Engineer - FDA Remediation (Drug / Combination Products) at Insight Global Process Engineer - FDA Remediation (Drug / Combination Products) at Insight Global in Tonawanda, New York Posted in 1 day ago.

Type:

full-time

Job Description:

Job Title:

Process Engineer - FDA Remediation (Drug / Combination Products)

Job Type:

Contract (W2) 12 months Shift /

Hours:

Day shift, standard business hours with flexibility for floor support

Pay Range:

$50-$60/ hr Overview A 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 Responsibilities Lead end?to?end assessment of manufacturing processes currently under FDA scrutiny Perform detailed process mapping to compare actual shop?floor operations against documented procedures Conduct comprehensive gap assessments across manufacturing processes, SOPs, and supporting documentation Author and remediate: Manufacturing SOPs and work instructions Process documentation, forms, and records Updated process flow diagrams 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) Partner directly with manufacturing operators, supervisors, and site leadership to ensure practical, compliant processes Support FDA inspections and remediation activities by ensuring documentation, FMEAs, and validation materials are inspection?ready Required Skills & Experience 5+ years of Process Engineering experience in an FDA?regulated manufacturing environment Strong drug cGMP expertise with working knowledge of 21 CFR Part 211 Drug manufacturing experience required (device?only backgrounds will not be considered) Working knowledge of 21 CFR Part 4 (combination products) Experience with FDA Process Validation Guidance Proven ability to work onsite, hands?on , and independently in manufacturing environments Experience engaging directly with operators and owning remediation efforts end to end Plusses Prior FDA remediation or inspection response experience Combination product manufacturing background Hands?on leadership of process validation execution