Overview
Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio.
This is a technical leadership role requiring application of advanced engineering principles in equipment, devices, process optimization, and manufacturing support. The position requires on-site support and be able to work flexible schedule based on operation demands and both on-site work and ~20% travel.
Base pay range
$42.00 / hr - $46.00 / hr
Key Functions & Outputs
Support technical transfer of product portfolio into the Ohio site.
Drive continuous improvement in device assembly and packaging line capacity / performance.
Communicate across the network to deliver technical milestones.
Act as site expert in automated / semi-automated device assembly.
Lead commissioning, qualification, and validation (CQV) of GMP equipment.
Own and maintain the site master validation plan.
Analyze, design, and implement manufacturing / business process improvements.
Drive productivity, throughput, and efficiency gains.
Able to author and manage various documents / protocols / reports
Deviation / CAPA / EV Owner
Change Control Owner
Build networks with commercial and clinical operations.
Provide support for equipment standardization, troubleshooting, and performance trending
Ideal Candidate
B.S. and 4 years of GMP experience, Packaging equipment experience,
technical writing & Document management system experience - Kneat or Viva preferred
The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio .
This is a technical leadership role requiring application of advanced engineering principles in equipment, devices, process optimization, and manufacturing support. The position requires on-site support and be able to work flexible schedule based on operation demands and both on-site work and ~20% travel
Preferred
Seniority level
Employment type
Job function
Industries
J-18808-Ljbffr
Packaging Engineer • New Albany, OH, US