6095 - CQV Engineer / Validation Engineer

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.

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.

) Provide technical leadership and mentorship to validation team members. Coordinate validation deliverables and execution schedules across multiple systems and workstreams. Interface with project leadership to communicate risks, resource needs, and project status.

Review and approve validation documentation prepared by junior team members. Drive resolution of complex qualification and startup challenges.

Requirements

Coordinate testing activities with Engineering, Manufacturing, Quality, and Vendor teams. Manufacturing Technical Support Support qualification of production equipment used in pharmaceutical manufacturing operations. Troubleshoot qualification and validation issues encountered during equipment startup and testing.

Review engineering documentation including P IDs, equipment specifications, drawings, and vendor documentation.

Assist in identifying and resolving deviations, discrepancies, and validation-related issues. Compliance Documentation Ensure all validation activities are executed in accordance with current GMP regulations and company procedures. Maintain clear, accurate, and compliant validation documentation.

Support change controls, deviations, CAPAs, and validation impact assessments as required. Participate in audits and inspections by providing validation subject matter expertise.

: Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. 3+ years of CQV, Validation, Commissioning, or Qualification experience (Validation Engineer). 7+ years of CQV, Validation, or Pharmaceutical Manufacturing experience (Lead Validation Engineer).

Experience supporting GMP-regulated pharmaceutical, biotech, medical device, or manufacturing environments.

Experience authoring and executing IQ/OQ/PQ protocols. Ability to work onsite in Bloomington, Indiana.