Senior Quality Assurance Engineer

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

Senior Quality Assurance Engineer

Location: Janesville, WI

Job Type: Full-time

Description

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.

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

• 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.

Requirements

• Bachelor’s degree in engineering, radiochemistry, life science, or related field.
• At least 5 years of quality experience in a cGMP pharmaceutical setting or at least 5 years of validation experience in a cGMP manufacturing setting, with experience in radiopharmaceuticals preferred.
• Demonstrated knowledge of Title 21 of the Code of Federal Regulations (CFR), with an emphasis on cGMP.
• Demonstrated knowledge of regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes, and facility systems.
• Demonstrated knowledge of various laboratory techniques/instruments such as spectroscopy (e.g., alpha/beta, gamma, UV/Vis), chromatography (e.g., IC, HPLC, TLC), trace metal analysis (e.g., AA, ICP), and wet chemistry techniques.
• Ability to communicate effectively with all levels within the organization, as well as interface with regulators, contractors, and suppliers.

Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls. Additionally applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre‑employment drug screen, fingerprinting and criminal background check.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.

SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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Employee Rights Under the NLRA

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