Responsibilities
* Develop, write, review, and execute process validation/process verification protocols and reports.
* Conduct risk assessments and develop validation strategies for new and existing processes.
* Analyze and interpret process validation data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
* Collaborate with Manufacturing, Quality, Design Transfer Operations, and other departments to resolve validation issues and implement corrective actions.
* Participate in process optimization and continuous improvement initiatives to enhance quality and efficiency.
* Ensure compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements.
* Provide training and guidance to manufacturing and quality personnel on validation processes and procedures.
* Maintain process validation documentation and ensure traceability and accessibility for audits and inspections.
* Other duties as assigned by management.
Qualifications
* Bachelor's Degree in Engineering or Life Science.
* Strong technical writing, analytical, and problem-solving skills.
* Knowledge of cGMP and regulatory standards.
* Strong understanding of process validation principles, techniques, and industry standards.
Pay ranges between $32-42/hr based on experience #J-18808-Ljbffr
* Develop, write, review, and execute process validation/process verification protocols and reports.
* Conduct risk assessments and develop validation strategies for new and existing processes.
* Analyze and interpret process validation data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
* Collaborate with Manufacturing, Quality, Design Transfer Operations, and other departments to resolve validation issues and implement corrective actions.
* Participate in process optimization and continuous improvement initiatives to enhance quality and efficiency.
* Ensure compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements.
* Provide training and guidance to manufacturing and quality personnel on validation processes and procedures.
* Maintain process validation documentation and ensure traceability and accessibility for audits and inspections.
* Other duties as assigned by management.
Qualifications
* Bachelor's Degree in Engineering or Life Science.
* Strong technical writing, analytical, and problem-solving skills.
* Knowledge of cGMP and regulatory standards.
* Strong understanding of process validation principles, techniques, and industry standards.
Pay ranges between $32-42/hr based on experience #J-18808-Ljbffr
Validation Engineer in tucson at Unknown Company
This position is listed as full time and onsite.