Verista, Inc.
Life Science
CQVEngineer/ValidationEngineer
Neural analysis suggests this role is
optimal for Mid+ candidates.
“CQV Engineer / Validation Engineer at Verista, Inc.. Skills: Commissioning, Qualification, Validation, GMP Compliance. Execute commissioning activities. Execute qualification activities”
Industry & Context.
Troubleshooting; Problem solving
Ability to work onsite
What They're Looking For.
Must Have
Bachelor's degree in Engineering, 3+ years CQV experience, 7+ years CQV experience, Experience supporting GMP-regulated environments, Understanding of validation lifecycle, Experience authoring IQ/OQ/PQ protocols, Ability to work onsite in Bloomington, Indiana
Nice to Have
Experience supporting startup of new manufacturing lines, Experience within pharmaceutical manufacturing, Familiarity with ISPE guidance, Familiarity with FDA guidance, Familiarity with EU GMP guidance, Familiarity with GAMP guidance, Experience managing deviations, Experience managing change controls, Experience managing risk assessments, Technical writing skills, Documentation skills
What You'll Do.
Execute commissioning activities
Execute qualification activities
Execute validation activities
Author validation lifecycle documentation
Review validation lifecycle documentation
Execute validation lifecycle documentation
Support startup activities
Support operational readiness activities
Perform field verification activities
Coordinate testing activities
Support qualification of production equipment
Troubleshoot qualification issues
Troubleshoot validation issues
Review engineering documentation
Ensure equipment meets GMP requirements
Ensure systems meet GMP requirements
Ensure equipment meets regulatory requirements
Ensure systems meet regulatory requirements
Ensure equipment meets internal quality requirements
Ensure systems meet internal quality requirements
Assist in identifying deviations
Assist in resolving deviations
Assist in identifying discrepancies
Assist in resolving discrepancies
Assist in identifying validation issues
Assist in resolving validation issues
Execute validation activities in accordance with GMP
Maintain validation documentation
Support change controls
Support validation impact assessments
Provide validation subject matter expertise
Provide technical leadership
Coordinate validation deliverables
Coordinate execution schedules
Interface with project leadership
Communicate resource needs
Communicate project status
Review validation documentation
Approve validation documentation
Drive resolution of challenges
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Coordinate with Engineering; Coordinate with Manufacturing; Coordinate with Quality; Coordinate with Vendor teams; Interface with project leadership
Communication Scope
Technical writing
Process & Methodology
Coordination of deliverables, Coordination of schedules
Full Job Description
Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise CQV / Validation Engineer Responsibilities: Commissioning, Qualification & Validation (CQV) Execute commissioning, qualification, and validation activities for manufacturing equipment, utilities, facilities, and process systems. Author, review, and execute validation lifecycle documentation including: Commissioning Protocols IQ (Installation Qualification) OQ (Operational Qualification) PQ (Performance Qualification) Validation Summary Reports Traceability Matrices Risk Assessments Support startup and operational readiness activities for new production equipment and manufacturing systems. Perform field verification activities, walkdowns, and documentation reviews to ensure systems are installed and functioning according to design requirements. Coordinate testing activities with Engineering, Manufacturing, Quality, and Vendor teams. Manufacturing & Technica
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