Process Development Engineer

Pinnaql is a leading services supplier in the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are seeking a Process Development Engineer to support the development, validation, and implementation of new manufacturing processes, focusing on equipment validation, process optimization, and collaboration with cross-functional teams.

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)

Requirements:

• 5–7+ years in manufacturing engineering or quality engineering within an FDA-regulated environment (medical devices, pharma, diagnostics, biotech)
• Strong working knowledge of 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