US Tech Solutions, Inc.
Duration: 24 months of contract Details: Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift Travel Requirement: Must be able to travel 20% required for this role Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience, technical writing & Document management system experience - Kneat or Viva 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. 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 Basic Qualifications: 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 Experience: 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: Expertise in Combination Product Assembly & Packaging Equipment: Strong knowledge of automated and semi-automated device assembly, validation, and troubleshooting Experience in GMP-Regulated Environments: Hands-on experience with technical transfer, regulatory compliance, and supporting commercial manufacturing operations Cross-Functional Project Leadership & Communication Skills: Proven ability to lead technical projects, work across teams, and effectively communicate in a regulated, fast-moving industry Strong technical writing skills. Day to Day Responsibilities: Serve as the technical lead for FDP assembly and packaging equipment (new and existing). Manage commissioning, qualification, and validation activities for GMP equipment, including ownership of the site’s master validation plan. Support technical transfer of new products into the site and ongoing optimization of packaging line performance. Provide manufacturing troubleshooting and equipment/process improvements. Build and leverage networks of technical experts across Company’s global sites. Support operational excellence initiatives to increase throughput, productivity, and efficieny 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, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.