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 environmentsAuthor and approve EMPQ Validation Plans and Qualification Protocols (QPs)Develop, review, and update environmental monitoring–related risk assessmentsProvide technical oversight for EMPQ execution using:Active air samplersPortable and fixed particle countersViable and non-viable EM monitoring devicesOversee validation readiness of microbiology support equipment, including:Incubators (20–25°C, 30–35°C, CO? where applicable)Biosafety cabinets (BSCs) and laminar flow hoodsColony countersReview and interpret EMPQ data, including trending, alert/action limits, and recovery expectationsAuthor Qualification Summary Reports and support QA review and approvalEnsure EMPQ activities align with FDA, EU GMP, ISO 14644, and internal quality standardsInterface with Validation, Quality, Facilities, Engineering, and Manufacturing stakeholdersMentor junior validation staff during protocol execution activitiesRequirements:8+ years of GMP validation experience in biotech or pharmaceutical manufacturingDemonstrated expertise in EMPQ protocol authoring, execution, and reportingStrong understanding of environmental monitoring programs and cleanroom control strategiesExtensive experience with EM and microbiology-related QC equipmentExcellent technical writing and regulatory communication skillsAbility to work independently in fast-paced onsite GMP environmentsBenefits: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.