Senior Process Engineer
Novozen Healthcare LLC · Massachusetts, United States
Apply & track with Apply EdgeKey Responsibilities
Design and develop manufacturing machines and automated equipment from concept to production.Support the transfer of products and processes from R&D/lab to commercial manufacturing.Lead equipment design, requirements, specifications, concepts, and design reviews.Design, commission, troubleshoot, and improve manufacturing equipment in pharmaceutical, medical device, or regulated environments.Improve equipment efficiency, process stability, reliability, automation, and manufacturing quality.Work with Product Development, Process Engineering, Manufacturing, Quality, Validation, Software, and Operations teams.Develop and maintain equipment requirements and technical documentation.Perform feasibility studies, calculations, testing, and proof-of-concept activities.Perform system and subsystem design using CAD and parametric modeling.Maintain CAD models, drawings, BOMs, specifications, and equipment documentation.Support equipment commissioning, qualification, validation, and production implementation.Work with vendors on equipment components, tooling, and subsystems.Perform tolerance stack-ups, statistical analysis, root-cause analysis, and process improvements.Troubleshoot equipment failures, process issues, and manufacturing problems.Ensure equipment and processes meet GMP, quality, safety, and regulatory requirements.Required:10+ years of engineering experience.Bachelor’s degree in Engineering or a related field.Experience in pharma, medical device, biotech, life sciences, or other regulated industries.Experience designing and building complex manufacturing equipment or machines.Strong experience with electromechanical systems and/or precision machine design.Experience taking equipment from development through commissioning and production.Knowledge of DFM, including sheet metal, machined, and welded parts.Experience working in regulated environments with strong documentation and change-control processes.Experience with automation, fluid/gas systems, motion control, hydraulics, laser cutting, vacuum systems, or automated assembly.Experience with GD&T, SolidWorks/PDM, and FMEA.Preferred:Experience with pharmaceutical manufacturing equipment, GMP environments, or FDA-regulated production.Experience with equipment qualification, commissioning, validation, or process validation.Experience with IQ/OQ/PQ documentation and execution.Experience with CAPA, deviations, change controls, and root-cause investigations.Rate: The hourly rate for this position is $50 per hour on W2 (DOE), subject to applicable employment terms.
Benefits
Benefits, if any, are subject to applicable employment terms, plan provisions, and eligibility requirements.Background Check: Background checks may be conducted in accordance with applicable federal, state, and local law.Work Authorization: Applicants must have valid U.S. work authorization as required by applicable law. Employment eligibility will be verified in accordance with applicable federal requirements.Equal Employment Opportunity: Employment decisions are made based on qualifications, merit, business needs, and other lawful criteria, without regard to characteristics protected by applicable federal, state, or local law.