Senior QA Engineer - cGMP Validation & Compliance

U.S. Fusion Energy; Shine (NC); On-site; USD 85,000 - 115,000; Full time

Job summary

SHINE Technologies is seeking a Senior Quality Assurance Engineer to support commissioning and qualification activities for cGMP products in the facility. The role requires knowledge of CFR Title 21 and extensive validation experience, with the candidate ideally having radiopharmaceutical exposure.

The base salary ranges from $85,000 to $115,000 per year, with comprehensive compensation. Located in Janesville, WI, the position is full‑time.

Qualifications

• Bachelor’s degree in engineering, radiochemistry, life science, or related field.
• At least 5 years of quality/validation experience in a cGMP setting, with radiopharmaceuticals preferred.
• Demonstrated knowledge of Title 21 CFR, with emphasis on cGMP.
• Experience with regulatory guidelines for test procedures, equipment, processes, and facility systems.
• Knowledge of laboratory techniques such as spectroscopy, chromatography, trace metal analysis, and wet chemistry.

Responsibilities

• Review and approve product specifications.
• Establish the Master Validation Plan.
• Develop SOPs for plant processes, equipment qualification, and revalidation of critical systems.
• Develop Process Validation plans and procedures for cGMP production.
• Develop Cleaning Validation processes and procedures for production processes.
• Collaborate with Chemistry to develop QC Lab Method Validations.
• Coordinate validation activities with internal and external stakeholders.
• Review data and prepare validation reports showing conclusions against specs.
• Develop Risk Matrix, FMEA/PFMEA, with mitigations.
• Develop Software Validation plans for internal controls.
• Establish Stability Testing plans and protocols.
• Establish packaging and labeling processes.
• Provide training on validation concepts.
• Perform Supplier Audits and maintain Approved Supplier List.
• Report progress to Leadership.

Skills

Quality assurance

Regulatory knowledge

Communication

Analytical thinking

Education

Bachelor’s degree in engineering, radiochemistry, life science, or related field

Tools

Spectroscopy

Chromatography (HPLC/IC/TLC)

Trace metal analysis (AA/ICP)

Wet chemistry techniques

Job description

SHINE Technologies is seeking a Senior Quality Assurance Engineer to support commissioning and qualification activities for cGMP products in the facility. The role requires knowledge of CFR Title 21 and extensive validation experience, with the candidate ideally having radiopharmaceutical exposure.

The base salary ranges from $85,000 to $115,000 per year, with comprehensive compensation. Located in Janesville, WI, the position is full‑time.