Staftonic LLC ยท 21 hours ago
CQV Automation Engineer
Indiana, United States
Contract
Onsite
Senior Level
7+ years expStaftonic LLC is seeking a CQV Automation Engineer for a long-term project located in Indiana. The role involves developing CSV and CQV documentation, executing validation protocols, and ensuring compliance with GMP standards while working closely with automation, engineering, and quality teams.
Information Technology & Services
Hiring Manager
Shaik Aleem
Responsibilities
Develop CSV and CQV documentation from scratch, including:
Functional Specifications (FS)
Design Specifications (DS)
Risk Assessments
Traceability Matrices
IQ, OQ, and PQ protocols
Create and execute DeltaV test scripts to validate:
Control modules, phases, alarms, interlocks, and batch logic
Perform IQ/OQ/PQ execution for DeltaV systems and controlled equipment
Support equipment and skid qualification (e.g., bioreactors, CIP/SIP, filtration systems)
Document test results, manage deviations, and ensure GMP compliance
Support 21 CFR Part 11 and data integrity requirements
Work closely with automation, engineering, and quality teams to ensure inspection-ready systems
Qualification
Required
7+ years of hands-on experience in DeltaV automation and validation
Strong experience with CSV and CQV in GMP pharma or biotech
Proven ability to author validation documents from blank templates
Hands-on execution of IQ, OQ, PQ for automation systems and equipment
Experience with Emerson DeltaV
Strong understanding of GMP, 21 CFR Part 11, and data integrity
Experience validating process equipment, skids, and utilities
Company
Staftonic LLC
At Staftonic, we believe in turning possibilities into realities.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase