Senior Quality Assurance Engineer

SHINE Technologies is seeking a Senior Quality Assurance Engineer who will assist the company in the development, review, and execution of Commissioning and Qualification activities for the facility utilities, equipment, and processes used in the manufacture and testing of cGMP products.

The base salary range for this position is $85,000 - $115,000 per year plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.

Duties and Responsibilities:

Specific duties and responsibilities of the Senior Quality Assurance Engineer include, but are not limited to:

• Review and approval of product specifications.
• Establish the Master Validation Plan.
• Develop necessary standard operating procedures for plant processes, equipment Commissioning and Qualification, and re-qualification and revalidation of critical systems and utilities.
• Develop Process Validation plans and procedures for cGMP-controlled production processes.
• Develop Cleaning Validation processes and procedures for production processes.
• Collaborate with the Chemistry team to develop QC Laboratory Method Validations.
• Coordinate and oversee scheduled validation and qualification activities with internal and external stakeholders.
• Review and analyze analytical and physical data generated from executed validation/qualification activities and prepare validation/qualification reports presenting conclusions on the validity of the processes based on objective evidence against product specifications.
• Develop Risk Matrix for production, FMEA/PFMEA, and collaborate with Engineering and Production to ensure mitigations are identified and implemented, including cleaning requirements and environmental monitoring procedures.
• Develop Software Validation plans and procedures for internal process controls.
• Establish reagent and product Stability Testing plans and protocols.
• Establish product packaging and labeling process and implementation.
• Develop and provide training and mentoring on validation concepts.
• Perform Supplier Audits and establish an Approved Supplier List.
• Report status and progress of validation/qualification activities or projects to the Leadership team.
• Perform other duties as assigned.