Pharma Packaging Line Validation Engineer

Pinnaql, Inc.

Fort Washington (Montgomery County)

On-site

USD 85,000 - 125,000

Full time

3 days ago
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Job summary

Validation & Engineering Group, Inc. seeks a hands-on Packaging Line Qualification Engineer/Technician to execute IQ/OQ/PQ for pharmaceutical packaging lines and support validation packs with objective evidence and deviations management.

You will troubleshoot mechanical, electrical, and automation issues, collaborate with Ops, QA, Maintenance, and Engineering, and ensure compliance with cGMP/GDP while maintaining data integrity.

Qualifications

  • Bachelor’s degree 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 experience.
  • Advanced automation coursework or certifications.
  • Familiarity with MES, EDMS/QMS systems.
  • Strong mechanical/electrical troubleshooting skills.
  • On-site availability and 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

Packaging line qualification
IQ/OQ/PQ execution
PLC basics
Vision/OCV systems
Electrical troubleshooting
Mechanical troubleshooting
On-site availability
Documentation compliance

Education

Bachelor’s in Mechanical/Electrical/Industrial Technology

Tools

MES systems
EDMS/QMS systems

Job description

Validation & Engineering Group, Inc. seeks a hands-on Packaging Line Qualification Engineer/Technician to execute IQ/OQ/PQ for pharmaceutical packaging lines and support validation packs with objective evidence and deviations management.

You will troubleshoot mechanical, electrical, and automation issues, collaborate with Ops, QA, Maintenance, and Engineering, and ensure compliance with cGMP/GDP while maintaining data integrity.

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