Senior Quality Assurance Engineer

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

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.

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.

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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