Validation Engineer

Actalent; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

Actalent is seeking a Validation Engineer to develop and execute validation, cleaning, and environmental control strategies within regulated cleanroom manufacturing operations. You will support multiple life sciences product lines and act as a technical liaison with internal teams and external customers.

The role focuses on validating manual cleaning, CIP, autoclaves, and heat sterilization, ensuring compliance with FDA/ISO standards and robust environmental monitoring programs across

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience validating in cleanroom environments and environmental monitoring.
• Understanding of FDA/ISO requirements for cleanroom and validation programs.
• Hands-on validation protocol development and execution.
• Familiarity with data integrity in regulated settings.

Responsibilities

• Develop and execute validation protocols for cleaning processes, CIP, autoclaves, and heat sterilization.
• Create and refine cleaning and disinfection protocols for contamination control.
• Plan and document ISO 5–8 cleanroom qualification activities and readiness assessments.
• Implement Environmental Monitoring Programs with sampling strategies and data review.
• Lead environmental program activities and coordinate with internal and external teams.
• Serve as a primary interface for environmental and validation topics with customers.
• Collaborate with engineers, quality, manufacturing, and consultants to support validation milestones.
• Support protocol drafting, execution, data analysis, and final reporting in a regulated environment.
• Ensure compliance with FDA, ISO, and life science regulations.

Skills

Validation in cleanrooms

Regulatory knowledge

Environmental monitoring

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related field

Job description

Job Description

Job Description

Job Title: Validation Engineer

Job Description

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.


• 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