We are seeking a hands-on
Packaging Line Qualification Engineer/Technician to execute and support equipment qualification (IQ/OQ/PQ) for pharmaceutical packaging operations. If you thrive in regulated environments, enjoy mechanical/electrical troubleshooting, and can produce clean, compliant documentation.
- Packaging Line Qualification Technician / Engineer
Description:
- 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.
- Write/revise validation deliverables: Validation Plans, Protocols, FAT/SAT checklists, RTMs, test scripts, VSRs.
- 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.
Qualifications:
- Bachelor's in Mechanical/Electrical/Industrial Technology or equivalent hands-on experience
- 3-7 years relevant experience in pharma/biologics/CMO
- 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
- Serialization/aggregation experience
- Vision/OCR/OCV inspection systems
- Advanced automation coursework or certifications
- Audit/inspection support experience
- Familiarity with MES, EDMS/QMS systems
- Strong mechanical/electrical troubleshooting skills
- On-site availability + willingness to work extended hours/weekends
- Clear communication; Spanish a plus depending on site
