Senior QA Engineer - cGMP Validation & Commissioning

SHINE Technologies; Janesville (WI); On-site; USD 85,000 - 115,000; Full time

Job summary

SHINE Technologies is seeking a Senior Quality Assurance Engineer who will assist in commissioning and qualification activities for facility utilities, equipment, and processes used in the manufacture and testing of cGMP products. The role requires at least 5 years in a cGMP pharmaceutical or validation setting, with knowledge of CFR Title 21 and regulatory guidelines.

You will develop validation plans, SOPs, risk assessments, and collaborate with multiple teams to ensure compliance and quality.

Qualifications

• Bachelor’s degree in engineering, radiochemistry, life science, or related field.
• At least 5 years of quality experience in a cGMP pharmaceutical or validation setting, with radiopharmaceuticals preferred.
• Demonstrated knowledge of CFR Title 21 and cGMP.
• Ability to communicate effectively with all levels, regulators, contractors and suppliers.

Responsibilities

• Review and approve product specifications.
• Establish the Master Validation Plan.
• Develop SOPs for plant processes, commissioning and qualification, and revalidation of critical systems.
• Develop Validation plans and procedures for cGMP production processes.
• Develop Cleaning Validation processes for production.
• Coordinate validation activities with stakeholders.
• Prepare validation reports with objective evidence against specifications.
• Develop Risk Matrix, FMEA/PFMEA, and mitigations with Engineering/Production.
• Develop Software Validation plans for internal controls.
• Establish Stability Testing plans and protocols.
• Develop packaging/labeling processes.
• Provide training on validation concepts.
• Perform Supplier Audits and maintain Approved Supplier List.
• Report progress to Leadership.

Skills

Quality assurance

Regulatory knowledge

cGMP knowledge

Communication

Validation planning

Education

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

Tools

Spectroscopy

Chromatography

Trace metal analysis

Wet chemistry

Job description

SHINE Technologies is seeking a Senior Quality Assurance Engineer who will assist in commissioning and qualification activities for facility utilities, equipment, and processes used in the manufacture and testing of cGMP products. The role requires at least 5 years in a cGMP pharmaceutical or validation setting, with knowledge of CFR Title 21 and regulatory guidelines.

You will develop validation plans, SOPs, risk assessments, and collaborate with multiple teams to ensure compliance and quality.