Sterilization Validation Consultant : New York, NY -- Long Term Contract

Cleaning and Sterilization Validation Consultant

Location: NY (100% Onsite)

Start Date: ASAP

Duration: 12 Months

Opportunity Summary:

• Client is launching a new state-of-the-art facility and is seeking an experienced Cleaning and Sterilization Validation Consultant to lead and execute key validation activities on the manufacturing floor. This is a hands-on, high-impact role ideal for a seasoned professional with deep expertise in autoclave validation and a proactive leadership style.

Key Responsibilities:

• Lead On-the-Floor Execution: Take full ownership of autoclave validation and steam sterilization activities, executing and overseeing operations in a fast-paced GMP manufacturing environment.
• Cycle Development: Design and optimize sterilization cycles for new and existing equipment, ensuring compliance with regulatory expectations.
• Training & Mentorship: Train, guide, and lead junior staff or peers in autoclave procedures, equipment use, and validation protocols.
• Technical Execution: Independently place thermocouples, execute temperature mapping, and perform data analysis using Kaye Validator or Ellab systems.
• Adapt and Support: Support cross-functional teams during buildout and commissioning activities; assist with VHP validation and additional cleaning validation as the facility scales.
• Proactive Engagement: Respond to alarms or deviations with urgency; step in to volunteer or lead when unexpected execution needs arise.

Required Qualifications:

• Extensive Autoclave Expertise: Proven hands-on experience leading autoclave cycle development, execution, and troubleshooting.
• Sterilization Knowledge: Strong technical command of moist heat (steam) sterilization, temperature mapping, and fixed equipment.
• Validation Tools Proficiency: Experience using Kaye Validator or Ellab data acquisition systems for thermal mapping and cycle qualification.
• Floor Leadership: Strong presence on the floor-must be capable of driving execution independently and efficiently with minimal oversight.
• Flexible and Reliable: Willingness to work off-hours (weekends, second shift) as needed to support project deliverables and changing timelines.
• Excellent Communication: Clear communicator and team collaborator with a hands-on, can-do attitude and a willingness to go above and beyond.

Preferred Skills:

• Experience with development-phase validation work.
• Background in cleaning validation or Vaporized Hydrogen Peroxide (VHP) sterilization.
• Demonstrated initiative and accountability-a go-to contributor who anticipates needs and acts without being asked.
• Prior experience in new facility startups or tech transfer environments is a strong plus.