Overview
Validation Engineer Jobs in Paramus, USA at Actalent
Validation Engineer
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.
Responsibilities
- 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.
Essential Skills
- 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.
Additional
Skills & Qualifications
- Experience in pharmaceutical, medical device, or broader life science manufacturing environments.
- Expo…
Title: Validation Engineer
Company: Actalent
Location: Paramus, USA
Category:
