Associate Engineer
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At a glance
Requirements
Credentials this posting asks for.
Job overview
Insight Global is hiring an Associate Engineer. The Associate Engineer will support qualification, validation, and compliance for Controlled Temperature Units and GMP‑regulated equipment, leading requalification and thermal mapping studies, executing protocols, investigating deviations, and maintaining documentation to meet regulatory and internal quality standards.
Key focus areas include Support qualification, validation, and compliance activities for Controlled Temperature Units and GMP‑regulated equipment, Lead requalification efforts and thermal mapping studies, and Execute qualification protocols and investigate deviations.
Important skills include Qualification, Validation, Compliance Activities, Requalification Efforts, Thermal Mapping Studies, and Protocol Execution.
Skills & qualifications
Skills
Qualifications
Full job description
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 [email protected] 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/.
Skills and Requirements
Bachelor's Degree in Engineering
1-2 years of experience working in a GMP environment
Comfortable being on site 5x a week CART experience
CQV exp
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