Validation Engineer jobs in United States
cer-icon
Apply on Employer Site
company-logo

KKR Consulting · 1 day ago

Validation Engineer

KKR Consulting partners with businesses to solve challenges and achieve lasting success, specializing in tailored consulting services across various industries. They are seeking a Senior Validation & Facilities Engineer to lead facility and equipment qualification in a GMP environment, focusing on execution and independent leadership.

Staffing & Recruiting
Hiring Manager
Satya CH
linkedin

Responsibilities

Lead and execute facility & environmental qualification
Smoke studies / airflow visualization (risk-based by Grade A–D)
Pressurization and differential pressure studies
Temperature mapping
EMPQ support for GMP rooms
Review and assess vendor commissioning and IOQ documentation
Determine when supplemental or wrapper protocols are required
Support qualification of process and laboratory equipment
Apply and justify representative qualification strategies
Perform P&ID walkdowns , redlines, and field verification
Author and execute validation protocols and reports
Coordinate with QA, Facilities, Engineering, Manufacturing, QC, and vendors
Provide clear weekly status updates highlighting progress and risk

Qualification

GMP environment experienceFacility qualificationEquipment qualificationTemperature mappingCommunication skills

Required

Independently lead facility and equipment qualification in a GMP environment
Lead and execute facility & environmental qualification
Smoke studies / airflow visualization (risk-based by Grade A–D)
Pressurization and differential pressure studies
Temperature mapping
EMPQ support for GMP rooms
Review and assess vendor commissioning and IOQ documentation
Determine when supplemental or wrapper protocols are required
Support qualification of process and laboratory equipment
Apply and justify representative qualification strategies
Perform P&ID walkdowns, redlines, and field verification
Author and execute validation protocols and reports
Coordinate with QA, Facilities, Engineering, Manufacturing, QC, and vendors
Provide clear weekly status updates highlighting progress and risk

Company

KKR Consulting

twitter
company-logo
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.

Funding

Current Stage
Early Stage
Company data provided by crunchbase