Hiring: Aseptic Manufacturing Risk Management Associate II Company: Simtra BioPharma Solutions Location: Bloomington, IN Job Posted Time: 2026-09-12 13:51:40 Employment Type: Contract Target Skills & Keywords : Microsoft Excel, Risk Management, Six Sigma About the job Experience: •2 years pharmaceutical industry experience in parenteral manufacturing Required Skills: •Provide guidance and technical expertise on regulatory requirements and company risk management processes. •Assess risks associated with non-conformances, complaints, audits, and change controls, and update process FMEAs as needed. •Review and approve risk assessments submitted through investigations, complaints, audits, change controls, and other quality system activities. •Author and approve risk assessments related to equipment, manufacturing process changes, facility modifications, and construction projects. •Author and approve deviation reports related to product and process issues. •Lead and support risk management activities for engineering, manufacturing, and process improvement projects. •Serve as the site Subject Matter Expert (SME) for risk management and provide guidance for risk remediation activities. •Support risk assessments for new processes and validation projects. Qualifications: •Bachelor’s degree required, preferably in a science or engineering related field •Minimum of 2 years pharmaceutical industry experience in parenteral manufacturing •American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification a plus. •Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Pilgrim, Veeva, Trackwise, etc.) •Must be able to wear appropriate personal protective equipment. •Duties may require overtime work, including nights and weekends •Use of hands and fingers to manipulate office equipment is required •Position requires sitting for long hours but may involve walking or standing for periods of time. •Must be able to gown for Grade C area •In return, you’ll be eligible for [1] Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!