Insight Global
Job Description
Insight Global is seeking an IT GxP Validation Lead for one of our clients in the Life Sciences/Pharmaceutical space. Our client focuses on utilizing technology to improve patient outcomes and creating new subsidiaries. This will be a 6-month contract to start with potential extensions and is able to sit fully remote in the United States.
In this role you will be responsible for creating validation plans, risk assessments and defining testing strategies for computer systems used in GxP environments. You will develop, review and execute test scripts to ensure systems function as intended and meet user requirements. You will be responsible for creating and maintaining all necessary documentation throughout the validation lifecycle, including plans, protocols, reports, and risk assessments. You will also ensure all validation activities are conducted in accordance with relevant regulatory requirements (e.g. FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and internal procedures.
Additional responsibilities will include:
Working closely with IT, Quality Assurance, business users, and other relevant teams to ensure seamless integration and compliance of validated systems.
Planning, executing, and maintaining the validation status of systems through change control and periodic review processes.
Training staff on validation processes and the use of validated systems.
Tracking, investigating, and resolving defects found during testing and validation phases.
Conducting risk assessments and implementing mitigation strategies to ensure systems are validated effectively.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .
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
5+ years of experience in GxP Systems Validation
Experience working in Life Sciences or Pharmaceuticals, specifically in a regulated environment)
Experience with FDA 21 CFR Part 11
Experience working with Veeva
Proficient with Microsoft Office Tools - Experience enhancing validation SOPs, templates, and documentation tools for continuous improvement
Certified Computer System Validation Professional (CSV) 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.
Insight Global is seeking an IT GxP Validation Lead for one of our clients in the Life Sciences/Pharmaceutical space. Our client focuses on utilizing technology to improve patient outcomes and creating new subsidiaries. This will be a 6-month contract to start with potential extensions and is able to sit fully remote in the United States.
In this role you will be responsible for creating validation plans, risk assessments and defining testing strategies for computer systems used in GxP environments. You will develop, review and execute test scripts to ensure systems function as intended and meet user requirements. You will be responsible for creating and maintaining all necessary documentation throughout the validation lifecycle, including plans, protocols, reports, and risk assessments. You will also ensure all validation activities are conducted in accordance with relevant regulatory requirements (e.g. FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and internal procedures.
Additional responsibilities will include:
Working closely with IT, Quality Assurance, business users, and other relevant teams to ensure seamless integration and compliance of validated systems.
Planning, executing, and maintaining the validation status of systems through change control and periodic review processes.
Training staff on validation processes and the use of validated systems.
Tracking, investigating, and resolving defects found during testing and validation phases.
Conducting risk assessments and implementing mitigation strategies to ensure systems are validated effectively.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .
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
5+ years of experience in GxP Systems Validation
Experience working in Life Sciences or Pharmaceuticals, specifically in a regulated environment)
Experience with FDA 21 CFR Part 11
Experience working with Veeva
Proficient with Microsoft Office Tools - Experience enhancing validation SOPs, templates, and documentation tools for continuous improvement
Certified Computer System Validation Professional (CSV) 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.