Engineer Senior
Job in
New Albany, Franklin County, Ohio, 43054, USA
Listed on 2026-06-04
Listing for:
US Tech Solutions, Inc.
Contract
position Listed on 2026-06-04
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering, Process Engineer, Automation Engineering
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
Description:
- 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.
- 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
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
Top 3 Must Have Skill Sets:
1. GMP & Packaging Equipment Expertise
- Strong hands-on experience in GMP-regulated environments
- Direct experience with packaging / device assembly equipment (automated or semi-automated)
- Involvement in commissioning, qualification, and validation (CQV)
- Proven ability to author and manage GMP documents (protocols, reports, validation docs)
- Experience with document management systems (preferably KNEAT or Veeva)
- Ownership of deviations, CAPAs, and change controls
- Ability to analyze and optimize manufacturing processes
- Experience driving efficiency, throughput, and performance improvements
- Strong technical leadership in process/equipment optimization
- Strong project management and team player skillset. Ability to work within different cross functional groups and coordinate projects.
Kneat/Veeva and Former experience managing projects
Day to Day Responsibilities:
1. Equipment & Manufacturing Support
- 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…
Position Requirements
10+ Years
work experience
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