Job Description
Insight Global is looking for an Associate Engineer to support one of their largest pharmaceutical clients within their C&Q department. This individual is responsible for supporting qualification, validation, and compliance activities for Controlled Temperature Units (CTUs) and other GMP-regulated equipment. This role will lead requalification efforts, thermal mapping studies, protocol execution, deviation investigations, and documentation activities to ensure compliance with regulatory requirements, internal quality standards, and site procedures. The position requires willingness to gain technical expertise in commissioning, qualification, validation (CQV), data integrity, and GMP documentation practices. Develop, execute, and document equipment qualification protocols in accordance with approved SOPs and validation plans. Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Maintain qualification packages, calibration records, validation reports, audit trails, and supporting documentation. Conduct thermal validation studies utilizing the Kaye Validator AVS system.
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.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
Bachelor's Degree in Engineering
1-2 years of experience working in a GMP environment
Comfortable being on site 5x a week
Nice to Have Skills & Experience
CART experience
CQV exp
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.