Pharma Packaging IQ/OQ/PQ Engineer Hands-On

Pinnaql, Inc.

Washington (Washington County)

Hybrid

USD 85,000 - 125,000

Full time

35 hours ago
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Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a hands-on Packaging Line Qualification Engineer/Technician to execute IQ/OQ/PQ for pharmaceutical packaging lines. The role requires troubleshooting across mechanical, electrical, and automation domains and delivering compliant documentation.

The position emphasizes collaboration with Ops, QA, Maintenance, and vendors to ensure equipment release readiness in a regulated setting with cGMP, data integrity, and CAPA support.

Qualifications

  • Bachelor’s in Mechanical/Electrical/Industrial Technology or equivalent hands‑on experience.
  • 3–7 years relevant pharma/biologics/CMO experience.
  • 3–4 years technician-level IQ/OQ/PQ execution.
  • Experience with packaging line qualification strongly preferred.
  • Basic PLC understanding; ability to read ladder logic/function blocks.
  • Vision/OCR/OCV inspection systems.
  • Advanced automation coursework or certifications.
  • Familiarity with MES, EDMS/QMS systems.
  • Strong mechanical/electrical troubleshooting skills.
  • On‑site availability + willingness to work extended hours/weekends.

Responsibilities

  • Execute IQ/OQ/PQ for packaging lines (cartoners, case packers, labelers, fill/plug/seal, conveyors).
  • Perform test execution, capture objective evidence, manage deviations, and support CAPA.
  • Support FAT/SAT with vendors and integrate test evidence into validation packs.
  • Troubleshoot mechanical, electrical, and automation issues (PLCs, HMIs, sensors, drives).
  • Work with scales, checkweighers, barcode/vision systems, and inspection equipment.
  • Partner with Ops, QA, Maintenance, Engineering, and suppliers to ensure equipment release readiness.
  • Maintain strict cGMP/GDP and data integrity standards.

Skills

IQ/OQ/PQ execution
Packaging line qualification
PLC basics
Vision systems
Automation certification
MES familiarity
QMS/EDMS familiarity
Troubleshooting
On-site readiness

Education

Bachelor's in Mechanical/Electrical/Industrial Technology

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a hands-on Packaging Line Qualification Engineer/Technician to execute IQ/OQ/PQ for pharmaceutical packaging lines. The role requires troubleshooting across mechanical, electrical, and automation domains and delivering compliant documentation.

The position emphasizes collaboration with Ops, QA, Maintenance, and vendors to ensure equipment release readiness in a regulated setting with cGMP, data integrity, and CAPA support.

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