Cleaning Validation Engineer

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at .

Key Responsibilities:

• Develop and maintain cleaning validation master plans, strategies, and lifecycle documentation
• Design scientifically justified cleaning validation approaches based on product toxicity, solubility, potency, and process risk
• Establish acceptable residue limits using health-based exposure limits (HBELs), PDEs, ADEs, and traditional cleaning validation approaches
• Author, review, and approve cleaning validation protocols and reports
• Coordinate execution of cleaning validation studies with Manufacturing, Quality Assurance, Quality Control, Engineering, and Validation teams
• Oversee equipment sampling activities, including swab and rinse sample collection
• Monitor validated cleaning processes through periodic reviews and continued process verification activities.

Requirements:

• 3+ years of pharmaceutical, biotechnology, medical device, or regulated manufacturing experience.
• Minimum 2 years of direct cleaning validation experience.
• Experience authoring validation protocols, reports, risk assessments, deviations, and CAPAs.
• Experience calculating HBEL, ADE, PDE, and MACO limits.
• Experience with toxicological assessments and health-based cleaning limits.

Benefits:

What We Offer:

• Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.