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 eliquent.com.

This position requires expertise in cleaning validation and monitoring in a cGMP facility. Key requirements include:

• Hands-on experience with CIP/SIP systems, washers, vessels, tanks, and manual cleaning.
• Development and execution of cleaning validation protocols and reports.
• Troubleshooting and optimizing CIP/COP systems, with experience in cycle development preferred.
• Data analysis and presentation of results, ensuring adherence to project specifications and timelines.
• Generation and resolution of protocol discrepancies.
• Review of GxP deliverables (specifications, procedures, validation documents).
• Training of operations staff on relevant protocols and procedures.
• Organization and tracking of validation activities to meet client timelines.
• Experience with various sampling techniques.
• Strong knowledge of cGMP requirements and excellent communication skills.
• Preferred skills: experimental design, problem-solving, organizational abilities, project management, discrepancy reporting, and root cause analysis experience.

Requirements

● Requirements:

• Engineering Degree
• Knowledge of FDA and cGMP regulations
• Able to review and interpret data for scientific conclusions
• Strong written, verbal, and technical writing skills
• Proficient in Microsoft Office; quick to learn new applications
• Hands-on experience with validation in a cGMP environment
• Excellent problem-solving and decision-making abilities
• Capable of extracting information from technical documents
• Proactive in project management and contingency planning
• Skilled in workload management and prioritization
• Able to work independently and multitask to meet deadlines
• Team player with the ability to collaborate effectively

Salary Range: 90k-100k

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.