Associate Manufacturing Technician

Associate Manufacturing TechnicianSingota Solutions is a contract development and manufacturing organization (CDMO) focused on getting products to patients faster by being agile, accountable, and transparent. Our team of experts believe in collaboration and customizing our services to assist our clients through the drug development process. Our key services include drug formulation development, analytical testing, aseptic filling, pharmaceutical labeling and kitting, and supply chain management.Why join Team Singota? We pride ourselves on a high-trust, high-accountability environment where we lift each other up. When you join Singota, you are a part of a team that respects, supports, and values its people. We celebrate wins together, brainstorm solutions together, and genuinely enjoy the work we do. The result? A team that's not just efficient, but also passionate, dedicated, and fun to work with.Job title: Associate Manufacturing TechnicianDepartment: ManufacturingLocation: Bloomington, IN (Onsite)Position Type: Full-time, non-exemptHours: 40 hr/wk, 1st shiftGeneral Description: Production operators actively participate in all the manufacturing operations for the company including:Sampling/DispensingDrug product formulationAseptic fillingFinished dose labeling/kitting/packagingPackaging Component Inspection (PCI)General:Must be able to work within the FDA regulated environment per 21CFR 210/211 requirements and those established by internal policy and standard operating proceduresComputer experience necessary. Proficiency with Microsoft Office (Outlook, Excel, Word)Experience using equipment HMIs, as well as ERP or inventory systems desiredAttention to detail and good organization skills mandatoryParticipate in and fully support process improvement initiativesAbility to work in both collaborative and independent work situations and environmentsMust strictly adhere to all safety requirements, including wearing proper PPE (personal protection equipment) while performing operations, i.e. respirator, safety glasses, gloves, etc.Job requires gowning to work in cleanroom environmentsPerform cleaning/disinfecting/sanitization of cleanroomsAssist in process investigations, writing of deviations, and implementation of CAPAs to continuously improve operationsAbility to stand for a minimum of 4 hoursMust have good documentation practices with clear, legible handwritingProvide recommendations and implement solutions to resolve equipment and/or process problems in a timely mannerComply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and proceduresGeneral support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the businessSampling/Dispensing:Pulling client material from warehouse for sampling and dispensing operations; putting client material away after operations completeSampling and dispensing client material from parent containers into smaller child containersWorking with hazardous and non-hazardous materials in a controlled environment and performing operations for short and long periods of timeFormulation:Precision weighing and measuring of buffers, excipients, API, etc.Ability to use basic lab instruments, such as; pH meter, conductivity meter, pipetsAbility to use basic manufacturing equipment, such as; biosafety cabinets, mixers, pumps, filter testersAseptic filling:Install machine change parts and load recipes on fill machineStaging/loading of components and preparation of fill pathPerform cleaning and VPHP decontamination of isolatorsFinishing (Labeling and Kitting):Label and package filled drug product and/or pharmaceutical components per written specifications, SOP's, job aids and batch recordsInspect product and printed materials for defectsResponsible for reconciliation of all controlled printed materials and productSetup and operation of labeling and packaging equipment and systemsPreparation and use of precision measuring instrumentsRequirements Skills and Physical Activity Requirements:Excellent work ethic and attention to detailRequires repetitive hand, wrist, arm motionsHand eye coordination and manual dexterity with small componentsUse of small tools and laboratory/production equipmentClear, legible handwritingAble to comprehend and execute complex written instructionsMust be able to lift, push, or pull up to 50 poundsEducation and Work Experience Requirements:High school diploma with 0-1 years industry experience orAssociates Degree in an Engineering or Science discipline with minimum 1 year industry experience OrBachelors Degree in an Engineering or Science disciplineBenefits:Dental insurance - effective day one of employmentHealth insurance - effective day one of employmentVision insurance - effective day one of employmentHealth savings accountLife & AD&D insuranceShort & long term disabilityPaid time off & holidaysEmployee Assistance ProgramTuition assistance401(k) with company matchSingota Solutions is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.