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Process Engineer - Capsules

Job in St. Louis, Saint Louis, St. Louis city, Missouri, 63105, USA
Listing for: Critical Fit Recruiting
Full Time position Listed on 2026-11-10
Job specializations:
  • Engineering
    Quality Engineering, Process Engineer
  • Manufacturing / Production
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 90000 - 120000 USD Yearly USD 90000.00 120000.00 YEAR

Job Description & How to Apply Below

Location: St. Louis

Process Engineer
- Compaction
- St. Louis, MO Area 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
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