Senior Process Engineer – Packaging Equipment, commercial GMP Final Drug Product operations; JP
Job in
New Albany, Franklin County, Ohio, 43054, USA
Listed on 2026-07-01
Listing for:
3 Key Consulting
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Quality Engineering, Packaging Engineer, Manufacturing Engineer, Process Engineer
Job Description & How to Apply Below
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
Position Requirements
10+ Years
work experience
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