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

Process Engineer Responsibilities

Meet with stakeholders and SMEs to gather input and develop PV protocols in preparation for and throughout Process Performance Qualification (PPQ)
Coordinate execution of PV protocols, including sampling plans, testing, data tracking, and data collection
Partner with internal functional groups (such as Manufacturing, Quality, Quality Control, and MSAT) and external CDMOs and contract laboratories to keep sampling, testing, and reporting on schedule
Provide day-to-day oversight of vendor and CDMO PV activities, tracking milestones, deliverables, and open items and escalating risks to SMEs and project leadership
Track and compile PV data, reviewing it for completeness and accuracy and flagging trends or unexpected results to SMEs
Support the documentation and resolution of deviations and discrepancies that arise during protocol execution
Summarize PV protocol execution and results in final reports, and prepare final packages for SME review and approval
Maintain protocol, sampling, and data trackers, communicate status and timelines to project stakeholders, and ensure all activities comply with GMP, internal procedures, and applicable regulatory requirements

Requirements

Bachelor's degree in Engineering (Chemical, Biomedical, Biochemical, or similar), Life Sciences, or a related technical field
2-5 years of experience in MSAT, process engineering, or manufacturing processes within a GMP-regulated pharmaceutical, biotechnology, or medical device environment
Working knowledge of process validation concepts, including PV protocols, PPQ, and sampling and testing strategies
Experience with CDMO or vendor oversight is valuable, including coordinating sampling, testing, and data collection across internal teams and external partners
Project management experience or demonstrated ability to track deliverables, timelines, and cross-functional action items is valuable
Strong technical writing skills, with experience drafting or contributing to protocols and summary reports
Strong organization, communication, and collaboration skills, with the ability to work with SMEs and cross-functional stakeholders and manage multiple activities and deadlines

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.