Process Engineer-Compaction

Critical Fit Recruiting
  • Saint Louis, Missouri
    Today

    Job Description

    RESPONSIBILITIES:

    • Specify, source, and justify pressing equipment, tooling, feed systems, and support equipment; manage installation, commissioning, and vendor relationships
    • Execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) and author the associated protocols
    • Partner with Facilities and ES&H on line layout, grounding and static control, containment, and operational siting under explosives safety program
    • Define and document the process: work instructions, travelers, control plans, and validated parameter windows
    • Manage tooling as a program — specification, sourcing, incoming inspection, wear tracking, changeover procedures, and replacement lifecycle
    • Establish in-process and final controls for dimensional, density, and integrity attributes; execute capability studies and sustain SPC
    • Troubleshoot production-stopping issues including weight and density variation, feed inconsistency, sticking and picking, tooling wear, and mechanical faults
    • Build and maintain the preventive maintenance program and spare parts strategy
    • Drive yield, throughput, scrap reduction, and cycle time improvement against defined cost targets
    • Train and qualify press operators; build sufficient bench depth so the line does not depend on any single individual
    • Support first article inspection, source inspection, and customer, prime contractor, and DCMA audits
    • Partner with Quality on nonconformance disposition, root cause analysis, and CAPA


    Required Qualifications:


    • B.S. in Chemical, Mechanical, Materials, or Industrial Engineering — or equivalent experience in a compaction-intensive manufacturing role
    • 5+ years in regulated manufacturing running or supporting compression, tableting, or compaction operations (pharmaceutical, nutraceutical, powder metallurgy, ceramics, catalyst, or similar)
    • Demonstrated hands-on experience with rotary or single-station presses, including setup, tooling changeover, troubleshooting, and teardown and rebuild
    • Working command of powder flow, blend uniformity, granulation, and compressibility, and how each factor drives finished compact quality
    • Experience authoring and executing qualification protocols and manufacturing documentation in an audited environment
    • Proficiency with statistical process tools including capability analysis, DOE, SPC, and Gage R&R
    • Must be a U.S. citizen or lawful permanent resident; visa sponsorship is not available
    • Must be able to qualify as an employee possessor of explosive materials under ATF regulations (27 CFR Part 555)


    Preferred Qualifications:


    • Experience with reactive, hygroscopic, moisture-sensitive, or otherwise environmentally sensitive blends where environmental control is integral to the process
    • Background in a materially accountable operation (DEA-registered, controlled substance, precious metal, or similar) where complete mass reconciliation is required
    • Prior experience standing up or significantly expanding a production line, cell, or facility
    • Depth in a formal quality management system — cGMP, ISO 9001, or AS9100
    • Powder metallurgy or technical ceramics pressing background
    • Ability to obtain and maintain a DoD security clearance


    Numbers & Facts

    LocationSaint Louis, Missouri

    Skills

    • AS 9100unmatched
    • Analysis Skillsunmatched
    • Auditingunmatched
    • Biotech and Pharmaceuticalunmatched
    • Code of Federal Regulationsunmatched
    • Commissioningunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cost Controlunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • DoD Clearanceunmatched
    • Documentationunmatched
    • Explosivesunmatched
    • ISO 9001unmatched
    • Identify Issuesunmatched
    • Industrial Engineeringunmatched
    • Machine Toolunmatched
    • Manufacturingunmatched
    • Powder Metallurgyunmatched
    • Preventative Maintenanceunmatched
    • Process Capabilityunmatched
    • Process Engineeringunmatched
    • Process Validationunmatched
    • Quality Managementunmatched
    • Reconciliationunmatched
    • Root Cause Analysisunmatched
    • Safety/Work Safetyunmatched
    • Security Clearanceunmatched
    • Time Managementunmatched
    • Travel Planningunmatched
    • United States Citizenunmatched
    • United States Department of Energy (DOE)unmatched
    • United States Drug Enforcement Agency (DEA)unmatched
    • Vendor/Supplier Relationsunmatched
    • Writing Skillsunmatched

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