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Quality Assurance Validation Engineer

Company: SHINE Medical Technologies
Location: Janesville
Posted on: May 13, 2019

Job Description:

Title: Quality Assurance Validation Engineer Location: Janesville, WI Job ID: 47645 col-wide Job Description: SHINE Medical Technologies is immediately seeking a Quality Assurance Validation Engineer to assist in the development, review and execution of facility utilities, process manufacturing equipment and testing of cGMP products. A good fit for a cross-functional engineer who enjoys working across an organization in Operations, Radiation Protection, Laboratory, Training, Construction, QA, Engineering, Procurement and Licensing. Potential activities include: - Establishing Master Validation Plans for plant processes, equipment installation and operational/performance qualification, requalification and revalidation of critical systems - Owning validation projects for all facility, equipment, manufacturing and cleaning - Develop and prepare validation protocols for commissioning and qualifications - Coordinate and oversee scheduled validation and qualification activities - Review and analyze analytical and physical data generated from executed validation/qualification activities - Work cross-functionally to generate risk management deliverables for new projects - Participate in change management system reviewing impact of changes to the validation/qualification status of all equipment, processes, software, and/or facilities - This position will report to the Quality Manager and will specifically focus on ensuring the safe, efficient, and effective operation of the facility. Qualifications Preferred: - Flexibility and attention to detail - Wiliness to learn about different processes and systems in a nuclear facility - Demonstrated proficiency with various laboratory techniques/instruments such as spectroscopy (alpha/beta, gamma, UV/Vis), chromatography (IC, HPLC, TLC), trace metal analysis (AA, ICP), and wet chemistry techniques - Working knowledge of current Good Manufacturing Process and/or Nuclear Regulatory Commission guidelines and standards. - Ability to apply and incorporate nuclear and pharmaceutical standards, rules and guidance's. (e.g. NRC, FDA, EU, ISO, ICH, ISPE, etc.) - Bachelor's degree in an Engineering discipline, Radiochemistry or Life Science degree - Four to seven years quality support experience in a cGMP pharmaceutical setting Eligibility for employment is conditioned on the applicant's ability to qualify for access to information subject to U.S. Export Controls regulations (U.S. Citizen or National, U.S. Permanent Resident, Asylee, or Refugee). 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 test, fingerprinting, and a criminal background checkSHINE 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. Check out the video on the Janesville, Wisconsin area by clicking the following link: ****************************************

Keywords: SHINE Medical Technologies, Janesville , Quality Assurance Validation Engineer, Engineering , Janesville, Wisconsin

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