6 дней назад
Process Engineer III - Packaging
80 000 - 121 250$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Process Engineer III - Packaging (GMP pharmaceutical packaging): Owning and validating primary and secondary packaging processes for combination products and pharmaceutical-device systems with an accent on automated packaging lines, serialization, and process control. Focus on leading complex troubleshooting, root cause investigations, validation activities, and capital improvements for OEE, yield, waste reduction, changeover time, and line reliability.
Location: USA - OH - West Chester
Salary: $80,000–$121,250 per year
Company
is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for medicines.
What you will do
- Own validated primary and secondary packaging processes, including serialization and aggregation systems where applicable.
- Maintain critical process parameters, critical quality attributes, operating ranges, and continued process verification activities.
- Act as the technical subject matter expert for automated and semi-automated cartoning, labeling, blistering, pouching, case-packing, and serialization lines.
- Lead troubleshooting, root cause investigations, deviation and complaint investigations, and change control activities.
- Author or approve URS, FAT/SAT, commissioning, and IQ/OQ/PQ documentation; lead process validation and revalidation.
- Lead packaging line improvements, technology transfers, new product introductions, equipment lifecycle planning, and capital projects.
Requirements
- Significant experience with pharmaceutical or combination-product packaging in a GMP-regulated environment.
- Experience with automated packaging equipment and line integration.
- Experience with process validation, including IQ/OQ/PQ, and lifecycle validation principles.
- Demonstrated experience leading investigations, root cause analysis, and change control processes.
- Bachelor’s degree in Mechanical, Chemical, Industrial, Biomedical, or related engineering discipline is preferred.
- Work authorization or visa sponsorship is not available for this position.
Nice to have
- Experience with serialization and aggregation systems.
- Experience supporting regulatory inspections.
- Project management experience with capital equipment or long-term improvement initiatives.
- Lean manufacturing or Six Sigma certification.
Culture & Benefits
- Annual cash bonus program.
- 401(k) plan with company match.
- Medical, dental, and vision coverage, plus life and disability insurance.
- Paid vacation, paid holidays, and other paid leaves of absence.
- Tuition reimbursement, family-building benefits, and caregiving support.
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