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Job Description

An employer is seeking a Quality Validation Engineer for a long-term opportunity in the Athens, GA location. This quality engineer will be tasked to support the IQ, OQ, PQ and documentation lifecycle for a growing pharmaceutical operation and the plant. Background with GMP and medical device validation is pivotal to this role as they will oversee multiple quality standards at a time. This role will heavily include research and deep understanding on 100300-page quality documents so that they can effectively help drive execution on the installation, qualification and operational qualifications and then help to audit and sign off after execution by the engineering team. This opportunity has the chance to expand to other teams following successful completion of the current open items and will play a pivotal role within the quality organization. The job duties will be performed on site and the ideal candidate can start by end of March.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

5+ years of quality engineering within medical device industry

5+ years of IQ, OQ, PQ validation

Experience managing CAPAs and PFMEAs

Comfortable with technical writing and documentation within QMS

Engineering or Business Degree J&J experience null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.