Senior Process Engineer

2-year, W2 contractNo C2C/C2H or visa sponsorships/transfersSummary: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 ~20% travelResponsibilities: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 our global sites.Support operational excellence initiatives to increase throughput, productivity, and efficiencyKey Functions & OutputsProject 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/reportsDeviation/CAPA/EV OwnerChange Control OwnerRelationships:Build networks with commercial and clinical operations.Provide support for equipment standardization, troubleshooting, and performance trendingBasic Qualifications:Doctorate (no experience required)ORMaster's + 2 years GMP experienceORBachelor's + 4 years GMP experienceORAssociate's + 8 years GMP experienceORHigh School/GED + 10 years GMP experiencePreferred:Combination product assembly equipment expertiseCross-functional project leadership experienceStrong teamwork and communication skillsDirect experience in devices, combination products, and packaging operationsSupplier management experience (FDP equipment vendors)Adaptability in regulated, fast-paced environmentsOperational excellence / continuous improvement mindsetPay range is $39 - $44 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.THE PROMISES WE MAKE:At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.For more information regarding our Privacy Policy, please visit /privacy.

Created: 2025-10-01