Validation Engineer

Project Validation Engineer

The Project Validation Engineer leads process validation activities for medical device manufacturing, ensuring that production processes, equipment, and automation systems are robust, compliant, and ready for release to production. This role combines hands-on work on the manufacturing floor with extensive documentation, protocol development, and collaboration across Quality, Manufacturing, and Engineering teams to support innovative, life-saving medical devices.

• Develop, author, and execute validation documentation, including IQ/OQ/PQ protocols, process validation plans, procedures, reports, engineering studies, and risk-based documentation.
• Partner closely with Quality, Manufacturing, and Engineering teams to draft, review, execute, and obtain approval for all validation deliverables.
• Evaluate manufacturing processes to understand product requirements, process flow, critical parameters, risks, and validation needs, and translate these into clear validation strategies.
• Support PPV and PQ-related activities for existing process backlogs, new product lines, and process transfers to ensure smooth and compliant implementation.
• Ensure all validation documentation follows established templates, internal standards, and applicable regulatory requirements for medical devices.
• Support automation and equipment capital projects from concept through installation and validation, ensuring equipment is properly qualified and ready for production use.
• Maintain and administer validation records within the company's quality management system, including documentation in Agile and other relevant tools.
• Spend time on the manufacturing floor to observe processes, support validation execution, troubleshoot issues, gather data, and verify that processes operate as intended.
• Perform significant office-based work to develop protocols, analyze data, prepare reports, and manage quality system documentation related to validation activities.
• Support process readiness and release-to-production activities after validation execution and approval, ensuring all requirements are met before manufacturing ramp-up.
• Work in a hands-on manner with process and equipment when needed, including direct interaction with manufacturing, assembly, automation, and molding systems.
• Track and report project outcomes, savings, and key performance indicators (KPIs) to demonstrate the impact and effectiveness of validation efforts.
• Assist with validation of manufacturing equipment, assembly equipment, automation equipment, molding processes, and plastics-related processes as required.
• Prepare and execute validation documents to ensure all automated systems are validated (IQ/OQ/PQ) and fully compliant with 21 CFR Part 820 and other applicable standards before release to production.
• Ensure compliance with FDA Quality System Regulations (QSR) and relevant product-specific regulations and standards, including IEC and ISO requirements.
• Champion Lean, Six Sigma, and Design for Manufacturability (DFM/DFA) principles across internal and outsourced operations to improve efficiency and product quality.

• Minimum of 3+ years of experience in medical device validation or process validation within a similar regulated industry.
• Bachelor's degree in Engineering or a related technical field.
• Strong background in medical device process validation and regulatory compliance, including IQ/OQ/PQ and 21 CFR Part 820.
• Experience working in the medical device field or another highly regulated manufacturing environment.
• Ability to complete complex technical reports and documentation clearly and accurately.
• Good computer skills, including proficiency with Excel for data analysis and documentation.
• Demonstrated ability to work hands-on with manufacturing processes and equipment while also managing detailed documentation.
• Experience with Agile documentation systems for managing validation records and quality documentation.
• Understanding of FDA QSR and relevant IEC and ISO standards related to medical devices.
• Experience with plastics processing or injection molding in a manufacturing environment.

• Scrum methodology experience and familiarity with working in an Agile environment.
• Experience championing or applying Lean and Six Sigma methodologies to improve processes and reduce waste.
• Knowledge of Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
• Ability to collaborate effectively with cross-functional teams in Quality, Manufacturing, and Engineering.
• Strong analytical and problem-solving skills, with the ability to evaluate process risks and critical parameters.
• Clear written and verbal communication skills for drafting protocols, reports, and presenting validation outcomes.
• Willingness to travel occasionally to Mexico to support validation and process transfer activities, as needed.
• Interest in contributing to innovative, life-saving medical devices in a collaborative, growth-oriented environment where…