Engineer Senior

Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift / Weekend10% travel required - Must be able to travel internationally for work (Europe/Canada)18 month contract to startIdeal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience,technical writing & Document management system experience - KNEAT or Veeva highly preferredThe 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% travelKey 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/reports- Deviation/CAPA/EV Owner- Change Control OwnerRelationships:- Build networks with commercial and clinical operations.- Provide support for equipment standardization, troubleshooting, and performance trendingQualifications- 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 experiencePreferredCombination 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 mindset