Job Description The Logistics (Shipping) Validation Engineer / Specialist will be responsible for overseeing and supporting the creation and management of logistics related validation records such as Operational Qualification (OQ), Performance Qualification (PQ) documents as well as support closure of quality records such as Change Controls, Deviations, CAPAs and Action Items related to Logistics Validation within the electronic quality record management system. The Engineer Specialist is a key resource within Logistics Validation team managing multiple studies and quality records within eQMS and ensure closure of the quality records by the agreed timelines. The Specialist coordinates or executes activities on multiple studies and takes the lead in managing the timelines and ensuring the completeness / technical merit of quality records in alignment with regulatory expectations. Key Duties and Responsibilities:  Support validation studies (Protocols, study executions, reports) required as part of new product launches and lifecycle management.  Support deviations to achieve right-first-time (RFT) completion and on-time phase completion, including deviation closure by the defined due date.  Ensure smooth transition of defined CAPA to the owning department SME and timely implementation to ensure on-time deviation closure.  Utilize both soft skills and technical skills to drive the deviation and CAPA processes effectively, including teamwork, collaboration, communication, technical writing, and vendor coordination.  Interface with Quality, Process Development, Regulatory, MSAT, Commercial and other Supply Chain Teams  Support other supply chain validation related projects as needed.  Strong foundation and demonstrated experience in: o Proactive communication to ensure deadlines are met and no quality record goes overdue o Basic understanding of GMP / GDP, as it relates to electronic recordkeeping o Basic understanding of Supply Chain Logistics o Experience authoring and using GxP documents such as SOPs and work instructions. o Understanding of Validation Concepts and experience in conducting validation studies in a regulated environment. o Excellent organizational skills o B.S in scientific or allied health field o Typically requires 4 years of experience or the equivalent combination of education and experience. 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/ . Skills and Requirements 1. High sense of urgency with the ability to multitask and understand how to pivot and reprioritize as business needs  2. GMP and GDP understanding manufacturing and documentation, excellent documentation practices  3. Validation experience- climate controlled practice  4. Experience with Operational Qualification (OQ), and Performance Qualification (PQ).  5. Technical writing- reports, protocols, etc. 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.