MV05-021226 Process Development Engineer

Job Description Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:Process Development EngineerRole Summary:The Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.Key Responsibilities:• Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.• Design and develop in-process and receiving inspection systems for new components and processes.• Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.• Manage process development projects from concept through implementation; collaborate with cross-functional teams.• Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.• Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).Experience Requirements:• 5-7+ years in manufacturing engineering or quality engineering within a regulated environment (medical devices, pharmaceuticals, diagnostics, biotechnology).• Strong working knowledge of pertinent regulations like 21 CFR Part 820, GMP, and ISO 13485.• Electrical and mechanical engineering background applied to automated manufacturing systems.• Experience with automation/controls, tooling, fixtures, test method development, and equipment qualification.• Proficiency in DOE, FMEA, CAPA, and root cause investigation.• Experience supporting new product introductions and process scale-up.Quality Expectations:Demonstrates commitment to patient safety and product quality by complying with all applicable quality procedures. Ensures proper documentation discipline and supports Quality System compliance.