EMPQ 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:

• Lead EMPQ planning, execution, and close-out for GMP cleanrooms and controlled environments
• Author and approve EMPQ Validation Plans and Qualification Protocols (QPs)
• Develop, review, and update environmental monitoring–related risk assessments
• Provide technical oversight for EMPQ execution using:
• Active air samplers
• Portable and fixed particle counters
• Viable and non-viable EM monitoring devices
• Oversee validation readiness of microbiology support equipment, including:
• Incubators (20–25°C, 30–35°C, CO? where applicable)
• Biosafety cabinets (BSCs) and laminar flow hoods
• Colony counters
• Review and interpret EMPQ data, including trending, alert/action limits, and recovery expectations
• Author Qualification Summary Reports and support QA review and approval
• Ensure EMPQ activities align with FDA, EU GMP, ISO 14644, and internal quality standards
• Interface with Validation, Quality, Facilities, Engineering, and Manufacturing stakeholders
• Mentor junior validation staff during protocol execution activities

Requirements:

• 8+ years of GMP validation experience in biotech or pharmaceutical manufacturing
• Demonstrated expertise in EMPQ protocol authoring, execution, and reporting
• Strong understanding of environmental monitoring programs and cleanroom control strategies
• Extensive experience with EM and microbiology-related QC equipment
• Excellent technical writing and regulatory communication skills
• Ability to work independently in fast-paced onsite GMP environments

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.