Associate Manufacturing Technician Job at Singota Solutions in Bloomington

Job DescriptionJD159 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: 1. Must be able to work within the FDA regulated environment per 21CFR 210/211 requirements and those established by internal policy and standard operating procedures2. Computer experience necessary. Proficiency with Microsoft Office (Outlook, Excel, Word).3. Experience using equipment HMIs, as well as ERP or inventory systems desired4. Attention to detail and good organization skills mandatory5. Participate in and fully support process improvement initiatives6. Ability to work in both collaborative and independent work situations and environments.7. Must strictly adhere to all safety requirements, including wearing proper PPE (personal protection equipment) while performing operations, i.e. respirator, safety glasses, gloves, etc.8. Job requires gowning to work in cleanroom environments9. Perform cleaning/disinfecting/sanitization of cleanrooms10. Assist in process investigations, writing of deviations, and implementation of CAPAs to continuously improve operations11. Ability to stand for a minimum of 4 hours12. Must have good documentation practices with clear, legible handwriting13. Provide recommendations and implement solutions to resolve equipment and/or process problems in a timely manner14. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures15. General 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:1. Pulling client material from warehouse for sampling and dispensing operations; putting client material away after operations complete2. Sampling and dispensing client material from parent containers into smaller child containers3. Working with hazardous and non-hazardous materials in a controlled environment and performing operations for short and long periods of timeFormulation:1. Precision weighing and measuring of buffers, excipients, API, etc.2. Ability to use basic lab instruments, such as; pH meter, conductivity meter, pipets3. Ability to use basic manufacturing equipment, such as; biosafety cabinets, mixers, pumps, filter testersAseptic filling:1. Install machine change parts and load recipes on fill machine2. Staging/loading of components and preparation of fill path3. Perform cleaning and VPHP decontamination of isolators4. Assist with environmental monitoringFinishing (Labeling and Kitting): 1. Label and package filled drug product and/or pharmaceutical components per written specifications, SOP's, job aids and batch records2. Inspect product and printed materials for defects3. Responsible for reconciliation of all controlled printed materials and product4. Setup and operation of labeling and packaging equipment and systems5. Preparation and use of precision measuring instrumentsRequirementsSkills and Physical Activity Requirements: 1. Excellent work ethic and attention to detail2. Requires repetitive hand, wrist, arm motions3. Hand eye coordination and manual dexterity with small components4. Use of small tools and laboratory/production equipment5. Clear, legible handwriting6. Able to comprehend and execute complex written instructions7. Must be able to lift, push, or pull up to 50 poundsEducation and Work Experience Requirements:1. High school diploma with 0-1 years industry experienceor2. Associates Degree in an Engineering or Science discipline with minimum 1 year industry experienceor1. Bachelors Degree in an Engineering or Science disciplineBenefits401(k)401(k) matchingDental insuranceHealth insuranceHealth savings accountLife insurancePaid time offTuition reimbursementVision insuranceSingota Solutions is an Equal Opportunity Employee