Aseptic Manufacturing Risk Management Associate II

Aseptic Manufacturing Risk Management Associate IIBloomington, Indiana, United StatesSimtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra.

We hold ourselves to the highest quality and regulatory standards.While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.The role:The Technical Services Associate II (Risk Management) is responsible for risk management activities associated with non-conformances, complaints, equipment validation, qualification and change control activities at the BPS site. This position interacts with clients, regulatory agencies, and cross-functional teams (Engineering, Technical Services, Manufacturing, etc.) to ensure timely approval of all associated documents.

This position reports to the Technical Services Validation Sr. Manager.The responsibilities: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.Utilize statistical tools to evaluate and analyze risk and process data.Perform annual reviews and updates of site process FMEAs to ensure continued effectiveness.Initiate, lead, and manage CAPAs and Change Control activities.Participate in regulatory inspections, audits, and compliance-related inquiries.Contribute to the development, maintenance, and continuous improvement of risk management procedures and practices.Required qualifications:Bachelor's degree required, preferably in a science or engineering related fieldMinimum of 2 years pharmaceutical industry experience in parenteral manufacturingAmerican 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.)Physical / Safety Requirements:Must be able to wear appropriate personal protective equipment.Duties may require overtime work, including nights and weekendsUse of hands and fingers to manipulate office equipment is requiredPosition requires sitting for long hours but may involve walking or standing for periods of time.Must be able to gown for Grade C areaIn return, you'll be eligible for:Day One BenefitsMedical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life InsuranceSpouse Life InsuranceChild Life Insurance401(k) Retirement Savings Plan with Company MatchTime Off ProgramPaid HolidaysPaid Time OffPaid Parental Leave and moreAdoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service ProgramEmployee Ownership PlanAdditional BenefitsShort and Long-Term Disability InsuranceVoluntary Insurance BenefitsVision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and moreOnsite Campus AmenitiesWorkout FacilityCafeteriaCredit UnionCurrent benefit offerings are in effect through 12/31/26DisclaimerThis job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job.

Simtra reserves the right to make modifications based on business requirements.Equal Employment OpportunitySimtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Data PrivacyTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy.