Validation-Focused Process Engineer (MedTech Manufacturing)

Katalyst CRO; Raynham (MA); On-site; USD 70,000 - 120,000; Full time

Job summary

Katalyst CRO in Raynham, MA is seeking a manufacturing/process engineer to lead validation activities and scale production. You will write and execute IQ/OQ/PQ, develop processes, specs, and operator instructions, and drive readiness through cross-functional collaboration with Operations, OpEx, Planning, Engineering and Quality teams.

The role requires 2-4 years in manufacturing or process engineering, strong technical writing, and hands-on validation experience in a regulated environment,

Qualifications

• 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.
• Hands-on experience with validation protocols.
• Experience in medical device and/or regulated manufacturing environment.

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.
• 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.
• Background in medical device or other regulated industries.
• Experience with machining, metal finishing, laser processing, or production automation.
• Practical exposure to machining, casting, finishing, laser processing, or automation.
• Knowledge of statistical data analysis tools (e.g., Minitab).
• Basic understanding of Geometric Dimensioning and Tolerancing.
• Willingness to support global projects, including travel.

Skills

Technical writing

Communication

Problem solving

Statistical analysis

Tools

Minitab

Microsoft Office

GD&T

Job description

Katalyst CRO in Raynham, MA is seeking a manufacturing/process engineer to lead validation activities and scale production. You will write and execute IQ/OQ/PQ, develop processes, specs, and operator instructions, and drive readiness through cross-functional collaboration with Operations, OpEx, Planning, Engineering and Quality teams.

The role requires 2-4 years in manufacturing or process engineering, strong technical writing, and hands-on validation experience in a regulated environment,