Process Engineer

Roles & Responsibilities

• Write and execute validation protocols and reports (IQ, OQ, PQ).
• Develop and implement manufacturing processes, specifications, operator instructions, process studies, and production readiness activities.
• C Conduct investigations, root cause analysis, problem solving, and prepare reports/presentations.
• Update procedures, manufacturing specifications, bills, routes, and travelers for product/process changes in PLM systems.
• Work with equipment manufacturers and distributors to develop user requirements.
• Partner with Operations, OpEx, Planning, Engineering, and Quality teams to align validation strategy, author documents, coordinate execution, and manage approvals.
• Ensure adherence to FDA regulations, regulatory requirements, company policies, and operating procedures.
• Identify opportunities for process improvement and implement best practices.
• Maintain positive and cooperative communication with employees, customers, contractors, and vendors.

Requirements

• 2-4 years of experience in manufacturing and/or process engineering.
• Strong technical writing skills with awareness of intended audience.
• Ability to effectively communicate with operators, peers, and management in both written and oral formats.
• Handson experience with validation protocols.
• Experience in medical device and/or regulated manufacturing environment.
• Persuasive communication and strong interpersonal abilities.
• Proficiency with Microsoft Office tools.