Validation Engineer - WI
Must be a US Citizen or Green card holder
Validation Engineer II
Overview
A growing engineering consulting and systems integration firm is seeking a Validation Engineer to support validation, quality, and compliance activities within regulated manufacturing environments. This position focuses on deviation investigations, root cause analysis, CAPA development, protocol execution, and validation documentation while partnering closely with operations, engineering, and quality teams.
Key Responsibilities
- Lead investigations into manufacturing deviations and non-conformance events.
- Conduct root cause analyses through interviews, documentation reviews, procedural assessments, and data analysis.
- Develop and support Corrective and Preventive Actions (CAPAs) to mitigate future occurrences.
- Prepare clear, accurate, and compliant investigation reports and validation documentation.
- Execute validation and qualification protocols in accordance with applicable procedures and quality standards.
- Verify that protocol acceptance criteria are met and appropriately documented.
- Organize qualification data, test results, reports, and supporting documentation within validation systems and equipment files.
- Perform field verification of equipment, systems, and related components.
- Build and maintain strong working relationships with clients and project stakeholders.
- Support manufacturing and operational teams as needed.
Additional Technical Support Opportunities
Depending on project requirements, the role may also include:
- Supporting PLC, HMI, DCS, and SCADA-based control systems.
- Assisting with troubleshooting and resolving automation-related issues.
- Supporting manufacturing equipment, process systems, and control platforms.
Qualifications
- Bachelor's degree in Engineering or a related technical discipline.
- 2-5 years of experience in validation, quality, manufacturing, engineering, or a related field.
- Strong technical writing and documentation skills.
- Basic data analysis and problem-solving capabilities.
- Ability to read and interpret electrical drawings and Piping & Instrumentation Diagrams (P&IDs).
- Strong organizational and communication skills.
- Ability to work independently and collaboratively within cross-functional teams.
Preferred Experience
- Validation or quality experience within regulated manufacturing environments.
- Pharmaceutical, biotechnology, life sciences, medical device, or similar industry experience.
- Familiarity with manufacturing and laboratory equipment.
- Experience supporting automation and control systems is a plus.
What You'll Gain
- Exposure to validation, quality, and manufacturing compliance projects within highly regulated environments.
- Opportunities for professional development, technical training, and career growth.
- Collaborative team environment with access to multidisciplinary engineering and manufacturing projects.
- Competitive compensation and comprehensive benefits package based on experience and qualifications.
FAQs
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