Kenosha, Wisconsin, 53140
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Job description
Job Summary
The Validation Engineer is responsible for ensuring that processes and systems meet rigorous standards and regulations. This role provides essential support in verifying and validating equipment, software, and processes, ensuring compliance with industry standards and internal policies.
Responsibilities
- Perform validation activities for various systems, equipment, and processes.
- Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Collaborate with cross-functional teams to create and maintain validation documentation and reports.
- Assist in troubleshooting and resolving validation-related issues.
- Ensure compliance with relevant regulatory requirements and internal quality standards.
- Participate in audits and inspections as necessary.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Proven experience in validation within a regulated environment.
- Knowledge of GxP, FDA, and ISO regulations.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
- Proficiency in documentation practices and software tools relevant to validation.
Location
Work Arrangement
On-site
Hunter International Recruiting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
