Process Engineer I

Simtra 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.Why join Team Simtra? Because we:Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.This RoleWe are looking for a Process Engineer I that is responsible for developing, implementing, and optimizing manufacturing processes to improve efficiency, quality, and productivity. This engineer will work closely with cross-functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards.The ResponsibilitiesDevelop User Requirement Specifications, Technical Specification and Design Specifications for new automated processing and packaging equipment or upgrades to existing equipmentAssist with authoring and executing protocols - including FAT, SAT, IQ and OQ documentsImplement improvement projects for utilities and department processesPerform process reviews and help Process Engineering team prepare technical reports detailing equipment operation, best practices, and recommended changesPerform validation maintenance reviews of process and utility systemsSuggest and develop energy and cost saving ideas and facility improvementsInterpret building prints and utility drawingsEvaluate and recommend products and systems in key technology areas.Prioritize tasks to resolve complex problemsDesirable QualificationsBS degree in Engineering required0-2 years of experience in process engineering in the pharmaceutical industryKnowledge of the basic principles in various engineering disciplinesPreferred experience in aseptic manufacturing environmentExperience with PLC, HMI, Vision Systems and Building Management systemsIntermediate or higher proficiency in Microsoft Word, Excel, and OutlookAbility to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)AutoCAD or equivalent component design knowledgeIn return, you’ll be eligible for[1]: Day One BenefitsMedical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life InsuranceSpouse Life InsuranceChild Life InsuranceShort and Long-Term Disability 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 ProgramAdditional BenefitsVoluntary Insurance BenefitsVision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and moreOnsite Campus AmenitiesWorkout FacilityCafeteriaCredit Union[1] Current benefit offerings are in effect through 12/31/24DisclaimerThis 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.EEO is the Law EEO is the law - Poster SupplementPay Transparency PolicyData PrivacyTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy