Senior Process Engineer – Packaging Equipment, commercial GMP Final Drug Product operations (JP15195)
$93,600–$104,000 year
On-siteNew Albany, Ohio, United States
Job Summary
Support commercial GMP Final Drug Product operations by providing on-site troubleshooting, analyzing manufacturing data to drive continuous improvement, and optimizing packaging line capacity and performance. Lead commissioning, qualification, and validation (CQV) activities, manage deviations, CAPAs, and change controls, and author GMP documents using KNEAT or Veeva. Drive technical transfer of the product portfolio into the Ohio site and collaborate with commercial, clinical, and vendor teams to deliver technical milestones. Work swing shifts including day, night, and weekends with approximately 10% international travel to Europe and Canada.
Required Qualifications
- B.S. and 4 years of GMP experience
- Packaging equipment experience
- technical writing
- Document management system experience
- KNEAT or Veeva
- Doctorate degree
- Masters degree and 2 years of experience
- Bachelor's degree and 4 years of experience
- Associate's degree and 8 years of experience
- High school diploma / GED and 10 years of experience
- Swing shifts (day/night/weekend as needed)
- 10% travel required
- Must be able to travel internationally for work (Europe/Canada)
- Must be available for weekend shifts
- Must be able to travel internationally for work (Europe/Canada)
- Must be able to travel internationally for work (Europe/Canada)
- Must be able to travel internationally for work (Europe/Canada)
Desired Qualifications
- Combination product assembly equipment expertise
- Cross-functional project leadership experience
- Strong teamwork and communication skills
- Direct experience in devices, combination products, and packaging operations
- Supplier management experience (FDP equipment vendors)
- Adaptability in regulated, fast-paced environments
- Operational excellence / continuous improvement mindset
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