Equipment Packaging Engineer

Title : Packaging EngineerLocation: Cambridge, MA 02138 ONSITEDuration: 24+ months Description:Swing shift - candidates need to have flexibility for different shifts. Dayshift / NightshiftIdeal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience,technical writing & Document management system experience - Kneat or Viva 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 ~20% 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/reportsDeviation/CAPA/EV OwnerChange Control OwnerRelationships:Build networks with commercial and clinical operations.Provide support for equipment standardization, troubleshooting, and performance trendingPreferredCombination 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 environments

Created: 2025-09-25