Job Information
US Tech Solutions Engineer Senior in New Albany, Ohio
$38.00-$44.84 per hour
New Albany, OH
Contract
Duration: 18 months Contract
Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift / 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.
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
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)
2. Technical Writing & Document Management Systems
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
3. Process Development & Continuous Improvement
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.
Nice to have: 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
2. Process Improvement & Optimization
Identify and implement process improvements to increase throughput and efficiency
Analyze manufacturing data to drive continuous improvement initiatives
Optimize packaging line capacity and performance
3. Documentation & Quality Systems
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
4. Validation & Technical Projects (CQV)
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
5. Cross-Functional Collaboration
Work with manufacturing, quality, engineering, and external vendors
Coordinate with commercial and clinical teams
Communicate progress on technical milestones and projects
6. Project & Vendor Management
Support equipment-related projects and timelines
Interface with equipment suppliers/vendors for troubleshooting and improvements
Contribute to standardization efforts across sites
7. Flexible Operations Support
Work swing shifts (day/night/weekend as needed)
Provide support based on production demands
Occasional travel (10%)
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .
"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"