Engineer Senior
Job in
New Albany, Franklin County, Ohio, 43054, USA
Listed on 2026-06-02
Listing for:
ACL Digital
Contract
position Listed on 2026-06-02
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering, Process Engineer, Packaging Engineer
Job Description & How to Apply Below
Swing shift - candidates need to have flexibility for different shifts. Dayshift / Night shift / Weekend
10% travel required - Must be able to travel internationally for work (Europe/Canada)
18 month contract to start
Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience,
technical writing & Document management system experience - KNEAT or Veeva highly 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 ~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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