Verista, Inc.

Life Science

CQVEngineer/ValidationEngineer

$88–109k Fishers, Indiana, United States
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“CQV Engineer / Validation Engineer at Verista, Inc.. Skills: Commissioning, Qualification, Validation, GMP Compliance. Execute commissioning activities. Execute qualification activities”

Industry & Context.

Life Science
Problems you'll solve

Troubleshooting; Problem solving

Eligibility Requirements

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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