Senior Process Engineer Packaging Equipment, commercial GMP Final

Senior Process Engineer – Packaging Equipment, Commercial GMP Final Drug Product Operations

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.

Key Functions & Outputs:

Project Management:

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.

Technical Leadership:

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.

Operational Excellence:

Analyze, design, and implement manufacturing/business process improvements.

Drive productivity, throughput, and efficiency gains.

Quality and Document Management Systems:

Able to author and manage various documents/protocols/reports

Deviation/CAPA/EV Owner

Change Control Owner

Relationships:

Build networks with commercial and clinical operations.

Provide support for equipment standardization, troubleshooting, and performance trending

Qualifications:

Basic (Education & Experience):

Doctorate (no experience required)

OR Master's + 2 years GMP experience

OR Bachelor's + 4 years GMP experience

OR Associate's + 8 years GMP experience

OR High School/GED + 10 years GMP experience

Preferred:

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