This role focuses on developing and executing validation, cleaning, and environmental control strategies within regulated cleanroom manufacturing operations. The Validation Engineer supports multiple high-profile, novel product lines in the life sciences space, including advanced tissue regeneration and innovative wound care hydrogel products. The position plays a key role in ensuring compliant, robust, and efficient validation of manual cleaning, sterilization, and environmental monitoring programs while serving as a technical liaison with internal teams and external customers.

• Develop and execute validation protocols for manual cleaning processes, clean-in-place (CIP) systems, autoclaves, and heat sterilization to ensure they meet regulatory and internal quality requirements.
• Create, implement, and refine cleaning and disinfection protocols that support consistent contamination control across manufacturing and cleanroom operations.
• Plan, perform, and document ISO 5–8 cleanroom qualification activities, including initial qualification and ongoing operational readiness assessments.
• Implement and maintain comprehensive Environmental Monitoring Programs, including sampling strategies, data review, and reporting to ensure a controlled manufacturing environment.
• Contribute to the development and execution of contamination control strategies, aligning procedures and controls with current regulatory expectations and industry best practices.
• Lead the environmental program for assigned projects, including coordinating activities, driving continuous improvement, and ensuring alignment with overall quality and validation strategies.
• Serve as a primary customer interface for environmental and validation topics, communicating technical information clearly and professionally to external stakeholders.
• Collaborate closely with cross-functional teams, including internal engineers, quality, manufacturing, and external consulting partners, to support validation activities and project milestones.
• Support validation activities within cleanroom operations, including protocol drafting, execution, data analysis, and final reporting in a regulated manufacturing environment.
• Ensure all validation and environmental monitoring activities comply with applicable regulatory standards and internal procedures, including FDA, ISO, and other relevant life science and medical device regulations.
• Participate in troubleshooting and root cause analysis related to environmental excursions, contamination events, or validation failures, and support the implementation of corrective and preventive actions.
• Maintain clear, accurate, and audit-ready documentation for all validation, cleaning, and environmental monitoring activities.

• Bachelor's degree in Engineering, Quality, or a related technical discipline.
• Experience supporting validation in cleanroom operations, contamination control, and environmental monitoring within a regulated manufacturing environment.
• Hands-on experience with cleaning validation and the development and execution of validation protocols for manual cleaning, CIP, autoclaves, and heat sterilization.
• Understanding of regulatory standards within manufacturing environments, including those applicable to pharmaceutical, medical device, FDA-regulated, and broader life science operations.
• Working knowledge of relevant regulatory and quality standards, including FDA requirements and ISO standards applicable to cleanroom and environmental control programs.
• Experience with ISO 5–8 cleanroom qualification and maintaining operational readiness.
• Background in implementing and supporting Environmental Monitoring Programs and contamination control strategies.
• Customer interfacing experience, with the ability to communicate technical validation and environmental information to external stakeholders in a clear and professional manner.
• Strong familiarity with validation protocols, documentation practices, and data integrity expectations in regulated environments.

• Experience in pharmaceutical, medical device, or broader life science manufacturing environments.
• Exposure to novel or advanced product lines, such as tissue regeneration or wound care technologies.
• Ability to work effectively with external consulting firms and integration partners on complex validation and environmental projects.
• Strong collaboration skills for working across engineering, quality, and manufacturing teams.
• Comfort interpreting and applying multiple regulatory and quality frameworks, i