Senior Technician Packaging 1st Shift 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 teams are driven to help clients scale innovate and bring life-changing medicines to patients worldwide.Why join Team SimtraBecause 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. The role:The Packaging Validation Associate I supports all aspects of the packaging process. This includes packaging development equipment validation and general finishing operations. The position supports Packaging Development including the defining of packaging requirements materials selection package design prototype development package testing and the development of all related packaging documentation. It also supports Packaging Validation including packaging equipment design specification development installation qualification vision tuning validation and operational support. This position reports to the Manager Packaging Validation.The responsibilities:Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environmentDevelops and executes Validation documentation including Process Flow Diagrams Failure Mode Effect Analysis (FMEAs) Protocols Final Reports Standard Operating Procedures (SOPs) etc.Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS)Participates in small project teams creates timelines tracks deliverables and communicates status updates to stakeholders.Formulates and recommends validation procedures and technical work in accordance with project and business objectivesParticipates in client and regulatory auditsSelects packaging materials; evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM) Component Specifications and Process Assembly SpecificationsActs as Change Control Management (CCM) Owner Non-Conformance and OCR (Out of Control Report) authorIdentifies and implements changes to Automated Inspection MachinesReviews and approves Packaging Technical Services documentsDesired qualifications:Bachelors degree in science or engineering related area is preferred or a minimum of 5 years manufacturing experience with 2 years of leadership experience required.In-depth process knowledge of related manufacturing equipment and process preferredExperienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferredAbility to review Equipment Manuals including Engineering Equipment Drawings and Electrical Schematic Diagrams.Proficiency in Microsoft Word Excel and Outlook and the ability to use enterprise software (examples include: JDE BPLM Trackwise etc.)Manages time effectively and independently within assigned responsibilitiesAbility to prioritize multiple projects/workflows and manage time efficiently in order to meet established timelinesOperates as a self-starter having the ability to complete tasks with minimal direction from managerExhibits a sense of urgency to meet timelines and key milestonesPossesses good leadership skills including ability to lead cross-functional departments in the implementation of new systems and modification of existing onesPhysical/Safety Requirements:Must be able to lift up to 25 lbs.Duties may require overtime work including nights and weekendsUse of hands and fingers to manipulate office equipment is requiredPosition requires sitting/standing for long hours but may involve walking or standing for periods of timeMust wear appropriate Personal Protective Equipment as applicableMust fully understand company safety rules and regulationsIn return youll be eligible for1: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 ProgramEmployee Ownership PlanAdditional 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:Senior IC Key Skills Engineering Maintenance,Invasive Cardiology,Graphics Design,Dodsal,Hotel Management Employment Type : Part-Time Experience: years Vacancy: 1