KKR Consulting · 1 day ago
Equipment Validation Specialist
Utah, United States
Contract
Onsite
Senior Level
5+ years expKKR Consulting is a company that partners with businesses to solve challenges and achieve sustainable growth. They are seeking an Equipment Validation Specialist to support the onboarding and qualification of new analytical laboratory equipment, ensuring compliance with GMP standards and data integrity expectations.
Staffing & Recruiting
Hiring Manager
Satya CH
Responsibilities
Plan, coordinate, and execute equipment qualification activities (IQ,OQ,PQ) for new and existing QC instruments
Work cross-functionally with Validation, IT and QA to ensure timely completion of qualification deliverables and data integrity compliance
Draft, review, and execute qualification protocols, test scripts, and PQ reports in accordance with GMP and company procedures
Perform PQ testing independently and/or in collaboration with QC-Chemist SME using analytical methods and the associated instruments SOP to confirm equipment performance
Partner with vendors and internal teams for equipment installation, calibration, and documentation review
Ensure qualification documents meets regulatory and audit-ready standards
Support Empower Chromatography System setup and integration activities for applicable instruments (bonus skill)
Contribute to laboratory readiness for method validation, release and stability testing
Maintain equipment lifecycle documentation, calibration schedules and change controls
Support deviation investigations, CAPA, and continuous improvement activities related to laboratory equipment and qualification
Qualification
Required
Bachelor's degree in chemistry, Biochemistry, or a related field
5 + years' experience in a GMP QC and Analytical Development environment
Proven experience in equipment qualification and validation across a range of analytical instruments
Hands-on analytical laboratory experience, able to execute PQ testing per analytical SOPs
Familiarity with data integrity, computer system validation and 21CFR Part 11 compliance
Demonstrated ability to manage multiple priorities and meet project timelines
Excellent interpersonal communication skills, able to work collaboratively with cross-functional partners
Preferred
Support Empower Chromatography System setup and integration activities for applicable instruments (bonus skill)
Company
KKR Consulting
At KKR Consulting, we collaborate with businesses across a wide range of industries to tackle complex challenges, fuel sustainable growth, and connect them with exceptional talent.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase