Validation Engineer: Cleanroom & Contamination Control

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

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