Summary

Verista, Inc. is a leading nationwide business and technology consultancy firm that provides comprehensive quality, compliance, validation, and automation solutions to regulated life science industries. Founded in 2020 through the unification of Clarke Solutions, Covex LLC, and Acquire Automation, the company serves pharmaceutical, biotech, medical device, and gene therapy companies with specialized expertise across the entire product lifecycle. With over 650 experts and a workforce of 501-1,000 employees, Verista delivers transformative solutions including computer systems validation (CSV), commissioning, qualification, and validation (CQV) services, manufacturing automation, packaging solutions, serialization, machine vision systems, FDA verification support, and data integrity management. Headquartered in Fishers, Indiana with additional offices in Pennsylvania, Massachusetts, and California, Verista bridges the gap between IT and operations, following repeatable processes that ensure regulatory compliance and operational excellence for some of the world's most recognizable life science brands.

Job description

Validation/CQV Engineer Responsibilities

Author, edit, and execute commissioning, qualification, and validation documentation (protocols, test scripts, and summary reports) for new equipment, systems, software, and processes introduced for NPI projects, as directed by the project leader
Execute approved test scripts, record results accurately in line with Good Documentation Practices (GDP), and document discrepancies for review and resolution
Support installation verification, FAT/SAT, and operational testing of new equipment and line modifications, confirming components against specifications and approved drawings
Support product changeovers and line readiness activities so new products can be introduced on schedule
Maintain clear, detailed, audit-ready qualification and validation records that support NPI launch readiness
Meet the project schedule for all assigned activities, communicating progress, risks, and timeline impacts to the project leader
Collaborate with NPI project teams, Engineering, Automation, Quality, and vendors to resolve test issues and keep documentation accurate and current

Requirements

Bachelor's degree in Engineering, Science, or a related technical field
1-3 years of experience supporting validation, qualification, or testing activities; internship or co-op experience will be considered
Experience in or supporting NPI, tech transfer, or new equipment and line introductions in pharmaceutical, medical device, combination product, or regulated packaging operations
Ability to read and interpret technical schematics and drawings, or willingness to learn quickly
GMP and Good Documentation Practice training
Proficiency with PC and Microsoft Office tools, including intermediate Word skills for authoring and editing large technical documents
Strong problem-solving, critical thinking, attention to detail, organization, and time management skills
Strong interpersonal and communication skills
Willingness to be on-site, full-time in Portland, ME

Benefits

Life Insurance
Short-Term Disability Insurance
Long-Term Disability Insurance
Medical, Dental & Vision
FSA
DCARE
Commuter Benefits
Supplemental Life Insurance
Hospital Insurance
Critical Illness Insurance
Legal Insurance
Health Savings Account
401(k) Matching
Paid Time Off
Holidays
Sick Time
Tuition Reimbursement
Employee Recognition
Employee Referral Program
Paid Parental Leave
Bereavement Leave

Company overview

Verista, Inc. is a leading nationwide business and technology consultancy firm that provides comprehensive quality, compliance, validation, and automation solutions to regulated life science industries. Founded in 2020 through the unification of Clarke Solutions, Covex LLC, and Acquire Automation, the company serves pharmaceutical, biotech, medical device, and gene therapy companies with specialized expertise across the entire product lifecycle. With over 650 experts and a workforce of 501-1,000 employees, Verista delivers transformative solutions including computer systems validation (CSV), commissioning, qualification, and validation (CQV) services, manufacturing automation, packaging solutions, serialization, machine vision systems, FDA verification support, and data integrity management. Headquartered in Fishers, Indiana with additional offices in Pennsylvania, Massachusetts, and California, Verista bridges the gap between IT and operations, following repeatable processes that ensure regulatory compliance and operational excellence for some of the world's most recognizable life science brands.