Project Associate II at Simtra BioPharma Solutions

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 teamsso we can solve problems in new ways.Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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 role:We are looking for a Project Associate II responsible for overseeing and maintaining Capital expenditure (Sustaining) including forecasting and adherence to financial policies. Additionally this role will lead small CAPEX projects and ensure they are delivered safely on time within budget and in compliance with Good Manufacturing Practices (GMP) regulatory requirements and company standards. The position works closely with cross-functional teams including finance manufacturing quality EHS maintenance validation and procurement to ensure successful project delivery. This position is 100% onsite at the Bloomington Indiana facility.Theresponsibilities:50% of time spent overseeing and maintaining Sustaining Capital expenditure including forecasting and adherence to financial policies50% of time spent managing CAPEX projects including setting scope budget and schedule are defined to meet project requirements and tracking deliverables for on-time project completionContinuously interacts with all functions and levels of management to forecast and report Capital expenditure and communicate consistently across teams and stakeholdersCollaborates with multifunction teams to develop project Capital Expenditure Requests (CERs) and Front-End Loading (FEL) documents among other documents required to obtain project approvalsTracks team deliverables for project completion to create and maintain project schedules to control project scope and to review contractor/engineering firm submittalsParticipates in all collaborations with external engineering firms in feasibility assessments concept design basic design and detail design. Anticipates potential conflict situations and manages to a successful outcomeFacilitates internal and external project reviews and assessmentsAmends and updates governing procedures and supports updatesSupports routing and approval of Engineering documentation.Closes Capital projects and turns in assets to finance counterpartsPresents project technical scope to site stakeholders and project sponsors/endorsersRequired qualifications: BS degree or relevant experience2 years of experience requiredExperience with capital project execution from concept to commissioningKnowledge of the basic principles in aseptic processing and/or inspection & packaging engineering best practicesMust be able to lead and execute engineering projects and lead multiple projects simultaneouslyStrong understanding of inspection and packaging materials processing and testing methodsExperience and/or knowledge of PLC HMI Vision Systems and Building Management SystemsStrong oral and written communication skillsLean Six Sigma or continuous improvement experience preferredMust be able to read mechanical electrical and P&ID drawingsAdvanced proficiency in Microsoft Office Suite (Word Excel and Outlook)Proficient in project management tools (MS Project Primavera JIRA etc.)Experience and the ability to use enterprise software (examples include: JDE Microsoft Dynamics BPLM Veeva Trackwise etc.)Physical / safety requirements:Duties may require overtime work including nights and weekendsPosition requires sitting for long hours but may also involve walking or standing for long periods of timePotential travel of 0-10% could be expectedMust be able to lift push pull and carry up to 50 lbsMust be able to lift 20 lbs overheadMust be able to wear personal protective equipment (PPE) as requiredIn return youll 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 Union1 Current benefit offerings are in effect through 12/31/25DisclaimerThis 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 Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy: Experience:IC Key Skills Project / Program Management,Primavera,IT Project Management,Microsoft Access,Public Health,Data Collection,PMBOK,Mobile Devices,Maximo,Prolog,Project Management,Microsoft Project Employment Type : Contract Experience: years Vacancy: 1