Senior Process Engineer – Packaging Equipment, commercial GMP Final Drug Product operations (JP15195)

3 Key Consulting•New Albany, OH

7d•Onsite

About The Position

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 ~10% travel.

Requirements

B.S. and 4 years of GMP experience
Packaging equipment experience
Technical writing & Document management system experience
Doctorate degree OR Masters degree and 2 years of GMP experience OR Bachelors degree and 4 years of GMP experience OR Associates degree and 8 years of GMP experience OR High School/GED and 10 years of GMP experience
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
Provide on-site support for GMP packaging and device assembly operations
Troubleshoot equipment issues and improve reliability/performance
Support automated and semi-automated assembly lines
Monitor and trend equipment performance metrics
Identify and implement process improvements to increase throughput and efficiency
Analyze manufacturing data to drive continuous improvement initiatives
Optimize packaging line capacity and performance
Write, review, and manage GMP documents (protocols, reports, procedures)
Own and manage deviations, CAPAs, and change controls
Maintain and update the site master validation plan
Use systems like KNEAT or Veeva for document control
Lead or support commissioning, qualification, and validation (CQV) activities
Support tech transfer of products into the Ohio site
Ensure equipment and processes meet regulatory and quality requirements
Work with manufacturing, quality, engineering, and external vendors
Coordinate with commercial and clinical teams
Communicate progress on technical milestones and projects
Support equipment-related projects and timelines
Interface with equipment suppliers/vendors for troubleshooting and improvements
Contribute to standardization efforts across sites
Work swing shifts (day/night/weekend as needed)
Provide support based on production demands
Occasional travel (~10%)

Nice To Haves

KNEAT or Veeva highly prefer

Responsibilities

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.