Manufacturing Operator II (Microspheres)

Manufacturing Operator II (Microspheres)Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.The Manufacturing Operator II (Microspheres) supports the preparation, mixing, inspection, filtration, and documentation of solutions used in the production of drug-loaded polymer microspheres. This role performs controlled manufacturing activities following approved Manufacturing Instructions, work instructions, and GMP requirements to ensure product quality, safety, and compliance.Key Responsibilities:Prepare solutions (weighing, mixing, heating, cooling, sampling, filtration)Operate mixers, jacketed tanks, TCU, peristaltic pumps, ultrasonic baths, bottle rollers, balancesPerform in-process inspections and environmental controlsComplete batch records and control documentation accuratelyFollow line clearance, cleaning, PPE, and safety requirementsEscalate deviations or out-of-spec results to supervision/engineeringOperating machinery to produce medical devices to meet the specificationsFollowing manufacturing instructions and updating the relevant job documentations accurately for traceabilityProduct packing and sterilization preparationProduct inspection using microscopePerform setup, verification of, and teardown of equipment before and after processingPrepare solutions and production materialsPerform manufacturing tasks, including fabrication, in-process testing, and packagingDocument production activities in manufacturing lot history recordsClean up production equipment and production areaPerform analysis of data (as needed)Troubleshoot product/process related issuesWork with chemicals and powders in a lab environmentQualifications:Required Qualifications:High-school diploma or equivalentMinimum 2 years of experience in a regulated manufacturing environment, preferably medical devicesProficiency in reading and following manufacturing instructions and drawingsStrong attention to detail, manual dexterity, and visual acuity for small-part assemblyBasic computer skills for data entry and documentationAdequate eyesight to ensure effective inspection of product, labeling and packagingAbility to work with potentially hazardous chemicals and safe handling of chemicalsAbility to work overtime and/or weekends, according to business needFluent in EnglishPreferred Qualifications:Experience with drug-coated balloons or catheter productionExperience with solution preparation, filtration, and samplingFamiliarity with cleanroom/controlled environmentsFamiliarity with cleanroom protocols and quality documentation systems (e.g., QMS or ERP platforms)Key Competencies:Dependable, punctual, and quality-focusedExcellent teamwork and communication skillsAbility to multitask and maintain accuracy under time constraintsPositive, solution-oriented attitude toward process improvementCommitment to safety, cleanliness, and regulatory complianceWorking Conditions:Cleanroom and controlled manufacturing environmentStanding and/or sitting for extended periodsFrequent use of microscopes, small tools, and measuring equipmentLight lifting (up to 25 lbs.)Must wear required PPE and adhere to EHS policiesPay / Compensation:The expected pre-tax pay rate for this position is $26.00 per hour. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location. US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.