Senior Quality Assurance Engineer

SHINE Technologies LLC•Janesville, WI

6d•$85,000 - $115,000

About The Position

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.

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.

Nice To Haves

experience in radiopharmaceuticals

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.