Validation Engineer

Validation EngineerThis 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.ResponsibilitiesDevelop 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 SkillsBachelor'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 & QualificationsExperience 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, including FDA guidance and various ISO standards.Attention to detail and a systematic approach to validation, documentation, and environmental monitoring activities.The Validation Engineer works within regulated cleanroom manufacturing environments, including ISO 5–8 classified areas, supporting advanced life science product lines. The role involves close collaboration with a small, focused project team, including other engineers and consultants who support key initiatives. The engineer partners with an external consulting firm on one of the major projects and regularly interacts with end customers to address environmental and validation topics. The position centers on hands-on validation, environmental monitoring, and contamination control activities in a setting that emphasizes regulatory compliance, technical rigor, and innovation in products such as tissue regeneration solutions and wound care hydrogels.Job Type & LocationThis is a Contract position based out of Paramus, NJ.Pay and BenefitsThe pay range for this position is $50.00 - $70.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in Paramus, NJ.Application DeadlineThis position is anticipated to close on Aug 24, 2026.