SHINE Technologies is seeking a Senior Quality Assurance Engineer to support the development, review, and execution of commissioning and qualification activities for facility utilities, equipment, and processes used in the manufacture and testing of cGMP products at the Janesville, Wisconsin site. The base salary range is $85,000 to $115,000 per year plus a comprehensive compensation package. Responsibilities include reviewing and approving product specifications; establishing the Master Validation Plan; developing SOPs for plant processes, equipment commissioning and qualification, and re-qualification/revalidation of critical systems and utilities; developing Process Validation and Cleaning Validation plans and procedures; collaborating with the Chemistry team to develop QC Laboratory Method Validations; coordinating validation activities with internal and external stakeholders; reviewing and analyzing data from validation/qualification activities and preparing reports with conclusions against product specifications; developing risk matrices (FMEA/PFMEA) and working with Engineering and Production to implement mitigations, including cleaning requirements and environmental monitoring; developing Software Validation plans and procedures for internal process controls; establishing stability testing plans and packaging/labeling processes; providing training and mentoring on validation concepts; performing Supplier Audits and maintaining an Approved Supplier List; reporting status and progress to leadership; and performing other duties as assigned. Qualifications include a Bac

SHINE Technologies is seeking a Senior Quality Assurance Engineer to support the development, review, and execution of commissioning and qualification activities for facility utilities, equipment, and processes used in the manufacture and testing of cGMP products at the Janesville, Wisconsin site. The base salary range is $85,000 to $115,000 per year plus a comprehensive compensation package. Responsibilities include reviewing and approving product specifications; establishing the Master Validation Plan; developing SOPs for plant processes, equipment commissioning and qualification, and re-qualification/revalidation of critical systems and utilities; developing Process Validation and Cleaning Validation plans and procedures; collaborating with the Chemistry team to develop QC Laboratory Method Validations; coordinating validation activities with internal and external stakeholders; reviewing and analyzing data from validation/qualification activities and preparing reports with conclusions against product specifications; developing risk matrices (FMEA/PFMEA) and working with Engineering and Production to implement mitigations, including cleaning requirements and environmental monitoring; developing Software Validation plans and procedures for internal process controls; establishing stability testing plans and packaging/labeling processes; providing training and mentoring on validation concepts; performing Supplier Audits and maintaining an Approved Supplier List; reporting status and progress to leadership; and performing other duties as assigned. Qualifications include a Bac