Engineer Senior

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 .

"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"