More jobs:
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
Job Description & How to Apply Below
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
- 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)
- 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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