Laboratory Validation Engineer (CSV)
Insight Global
We are seeking a skilled and detail-oriented Laboratory Validation Support Engineer to join our team. The primary responsibility of this role is to ensure that all laboratory systems and equipment are validated and compliant with regulatory standards, with a strong emphasis on documentation. The ideal candidate will have a strong technical background in pharmaceutical processes, computer system validation (CSV), and a keen eye for detail.
Responsibilities:
Develop and execute validation protocols for laboratory equipment, systems, and processes.
Conduct validation tests and analyze results to ensure compliance with internal and external regulations.
Document all validation processes and test results for future reference and audits.
Identify potential issues or malfunctions and develop solutions to address them.
Update and maintain validation protocols and standard operating procedures (SOPs).
Train staff on validation procedures and protocols.
Review and approve validation reports.
Stay up-to-date with the latest industry trends and regulatory standards.
Collaborate with validation engineers, quality assurance (QA) teams, and documentation specialists to ensure comprehensive validation coverage and compliance.
Support change control activities by assessing the impact of changes on validated systems and processes, and ensuring that all changes are properly documented and validated.
Focus on creating, updating, and maintaining comprehensive documentation for all laboratory validation activities.
Utilize PDOCs and Kneat software systems for electronic documentation and validation management
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/ .
Responsibilities:
Develop and execute validation protocols for laboratory equipment, systems, and processes.
Conduct validation tests and analyze results to ensure compliance with internal and external regulations.
Document all validation processes and test results for future reference and audits.
Identify potential issues or malfunctions and develop solutions to address them.
Update and maintain validation protocols and standard operating procedures (SOPs).
Train staff on validation procedures and protocols.
Review and approve validation reports.
Stay up-to-date with the latest industry trends and regulatory standards.
Collaborate with validation engineers, quality assurance (QA) teams, and documentation specialists to ensure comprehensive validation coverage and compliance.
Support change control activities by assessing the impact of changes on validated systems and processes, and ensuring that all changes are properly documented and validated.
Focus on creating, updating, and maintaining comprehensive documentation for all laboratory validation activities.
Utilize PDOCs and Kneat software systems for electronic documentation and validation management
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/ .
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