ATLCQV Specialist; Automation/CSV/Laboratory – NC
Listed on 2026-01-17
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Engineering
Validation Engineer, Automation Engineering -
Manufacturing / Production
Validation Engineer, Automation Engineering
Validation & Engineering Group, Inc. (V&EG) is a leading technical services provider specializing in Commissioning & Qualification (C&Q), Computer System Validation (CSV), Validation, Compliance, Quality Assurance, and Engineering services for the Biotechnology, Pharmaceutical, Advanced Therapies, Medical Device, and Chemical (API) industries.
Position OverviewThis role is CSV and automation-focused
, working directly with the client’s automation and manufacturing systems teams
. The individual will be responsible for assessing, validating, and qualifying changes to previously qualified automated manufacturing lines and systems within an FDA-regulated environment.
- Liquid and lyophilized vial lines with RABS technologies
- Fully isolated syringe and vial combination lines
- Highly automated and robotic manufacturing systems
In addition to automation and manufacturing systems, the role may also provide CQV support for laboratory systems when needed.
Key Responsibilities- Lead and execute Computer System Validation (CSV) and automation-related qualification activities for manufacturing systems.
- Assess, document, and qualify changes to previously qualified manufacturing lines, equipment, and automated systems.
- Support and validate PLC changes, SCADA changes, and automation system modifications.
- Perform automation validation, including understanding and assessing PLC logic and programming.
- Collaborate closely with automation, engineering, and manufacturing teams.
- Support qualification and validation of:
- Automated manufacturing process equipment
- Cleanroom Building Management Systems (BMS)
- Clean utilities and related control systems
- Select IT-related systems, as applicable
- Author, execute, and review validation documentation (IQ, OQ, PQ, CSV deliverables) in compliance with cGMP, FDA, EMA, and site requirements.
- Perform risk assessments, discrepancy resolution, deviation investigations, and support change control and CAPA activities.
- Provide clear project status updates and support timely release of systems for manufacturing use.
- Support laboratory systems CQV activities as needed.
- Bachelor’s degree in engineering, computer science, life sciences, or a related technical discipline.
- Minimum 5 years of experience in CSV, automation validation, and CQV within pharmaceutical, biotech, or other FDA-regulated environments.
- Hands‑on experience with:
- PLC-controlled systems
- SCADA systems
- Automation change management and validation
- Strong understanding of:
- Automated manufacturing process equipment
- CSV principles and lifecycle documentation
- cGMP, 21 CFR Part 11, EU Annex 11, data integrity requirements
- Experience supporting complex manufacturing systems, including robotic or highly automated lines.
- Experience with aseptic manufacturing operations (filling, lyophilization, isolators, RABS).
- Strong technical writing, organizational, and communication skills.
- Ability to work independently in a fast‑paced, on‑site manufacturing environment.
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