Equipment Packaging Engineer

Title : Packaging Engineer***** Cambridge, MA 02138 ONSITE ***** 24+ months***** Swing shift - candidates need to have flexibility for different shifts. Dayshift / NightshiftIdeal ***** 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 & Outputs Project ***** - 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 ***** - 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 ***** - Analyze, design, and implement manufacturing/business process improvements. - Drive productivity, throughput, and efficiency gains.Quality and Document Management ***** - Able to author and manage various documents/protocols/reports - Deviation/CAPA/EV Owner - Change Control Owner***** - Build networks with commercial and clinical operations. - Provide support for equipment standardization, troubleshooting, and performance trendingPreferred 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

Created: 2025-09-25