CSV/CQV Engineer – Kneat

JC Automation Corp•Remote US, US, PR

9h•Hybrid

About The Position

The CSV/CQV Engineer will support commissioning, qualification, and computer system validation activities for new and modified equipment, utilities, facilities, automated systems, and computerized systems within a regulated pharmaceutical manufacturing environment. This position will work closely with Engineering, Automation, Manufacturing, Quality, IT, system owners, vendors, and other project stakeholders to develop and execute validation strategies and deliverables in accordance with project requirements, company procedures, cGMP requirements, and applicable regulatory standards. The role requires hands-on experience using Kneat as a paperless validation and qualification platform.

Requirements

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a closely related technical discipline.
Minimum of three years of experience in commissioning, qualification, computer system validation, quality, engineering, automation, or pharmaceutical manufacturing.
Demonstrated experience developing and executing CSV and CQV documentation, including IQ, OQ, and PQ protocols.
Hands-on experience with the Kneat paperless validation platform is required.
Working knowledge of cGMP, FDA requirements, 21 CFR Part 11, data integrity principles, and GAMP 5.
Experience with validation lifecycle documentation, risk assessments, requirements traceability, test execution, deviations, and final validation reports.
Experience with computerized systems, automated manufacturing systems, PLC/SCADA environments, laboratory systems, or process-control systems.
Ability to interpret technical documentation and translate system requirements into appropriate validation and testing strategies.
Strong technical writing, analytical, organizational, and problem-solving skills.
Strong interpersonal and communication skills with the ability to work effectively across Engineering, Quality, Automation, IT, Manufacturing, and external vendors.
Ability to manage multiple assignments and work independently within established project timelines

Nice To Haves

Experience working in pharmaceutical, biotechnology, medical-device, or another highly regulated manufacturing environment.
Experience supporting system implementation, migration, upgrades, and decommissioning activities.
Knowledge of ALCOA+ data integrity principles.
Experience supporting regulatory inspections and audit-readiness activities.
Experience with change control, CAPA, deviation management, periodic review, and maintaining systems in a validated state.

Responsibilities

Develop, review, execute, and approve commissioning, qualification, and computer system validation documentation.
Prepare and execute validation plans, User Requirements Specifications, functional and design specifications, risk assessments, traceability matrices, test scripts, protocols, and final reports.
Develop and execute IQ, OQ, and PQ protocols for equipment, utilities, facilities, automated systems, and computerized systems.
Use Kneat to create, route, execute, review, approve, and maintain electronic validation and qualification documentation.
Ensure validation deliverables comply with applicable cGMP requirements, internal procedures, validation standards, and regulatory expectations.
Apply risk-based validation principles in accordance with GAMP 5 and applicable data integrity requirements.
Support Factory Acceptance Testing, Site Acceptance Testing, commissioning, system verification, and equipment release activities.
Evaluate computerized and automated systems to ensure they remain in a validated state throughout their lifecycle.
Support validation activities involving automation systems, PLCs, SCADA, process-control systems, laboratory systems, manufacturing systems, and related interfaces.
Review system changes, deviations, validation discrepancies, and test exceptions, and support the development and implementation of appropriate corrective actions.
Support investigations, CAPAs, change controls, periodic reviews, and requalification or revalidation activities.
Maintain complete, accurate, traceable, and inspection-ready validation documentation.
Collaborate with cross-functional teams and contract validation resources to ensure timely completion of project deliverables.
Provide validation support during internal audits, client audits, and regulatory inspections.
Manage multiple validation activities and priorities while meeting established project schedules.