Clean Room Manufacturing Operator 2

Overview The Manufacturing Operator II will perform pre‑ and post‑formulation processing such as blending, mixing, pouring, loading, product cutting, inspection, defect identification, packaging, machine packaging operations, labeling, and boxing to produce finished goods. The role also includes subassembly post‑chemical processing such as crosslinking to produce collagen‑based products. Shift Details This is a first shift (7:00a.m.–3:30p.m.), Monday through Friday. Shift flexibility and occasional overtime may be required to meet batch milestone requirements. Responsibilities Operate, maintain, and troubleshoot process equipment utilized in the collagen business and make minor equipment adjustments as needed. Perform precise measurements and use measurement equipment to accurately add chemicals to batches. Blend, mix, pour, and load collagen‑prepped material into lyophilizing equipment. Pass and maintain gowning qualification to perform gowning requirements for ISOClass5 and ISOClass7 cleanroom operations. Maintain legible and accurate records, required logs, books, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations (QSR), Standard Operating Procedures (SOPs), and Health and Safety requirements. Interface with QA/QC/Material departments to coordinate inspections and efficient flow of subassemblies and completed products. Enter and record production activities in Oracle MRP systems to issue material and labor hours to specific work orders. Follow applicable SOPs, QSR and ISO13485 requirements. Handle, decontaminate, and clean production supplies, instruments, and equipment to support all cleanroom production activities. Report all discrepancies to the Supervisor or Group Leader. Support department and plant safety goals by continuously demonstrating safe behavior. Support training as required by the department management. Work flexible shifts or days within the week to meet batch milestone requirements. Qualifications High School diploma or equivalent; a degree in a related science a plus. 2+years of chemical processing experience or batch mixing in medical device or pharmaceutical manufacturing industry; cleanroom production experience highly desirable. Basic computer skills for email and data entry. Proficient in reading, writing, and speaking English, and communicating clearly and concisely. Fundamental understanding of mathematics and chemistry. Ability to participate in a team‑oriented environment, assist and train others. Ability to work independently with minimal supervision. Ability to operate, maintain, and troubleshoot process equipment, and make minor adjustments as needed. Ability to gown to ISOClass5 and ISOClass7 cleanroom standards. Willingness to work overtime. Tools and Equipment Used Lyophilizers Autoclave Homogenizers Grinder Vacuum pump pH meters Thermometers Balances (scales) Water bath circulators Sonicators Humidity cabinet Mixers Centrifuge Blenders Air gun Drop indicator Filamatic filling machines Slicer machines Scalpels Temperature recorders Crosslinking chamber Humidification chamber Compression unit Cutting table Sealing machines Shrink wrap machines Physical Requirements Stand for 8 hours; sit, listen, speak, and write/type during work. Lift up to 60lb and climb ladders without assistance; bend and lift 30‑60lb daily. Stand for 8 hours; climb step ladders without assistance. Gown to ISOClass5 and ISOClass7 cleanroom standards. Normal color perception and visual acuity of 20/25 to detect defects. Compensation Hourly wage range: $21.12–$27.98USD. Employees may be eligible for bonus, commission, equity, or other variable compensation. Benefits Core benefits include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and a 401(k) savings plan. Equal Opportunity Employer Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This organization operates in compliance with applicable U.S. laws and governmental regulations. If you have difficulty using our online system due to a disability and need an accommodation, please email us at View email address on click.appcast.io. #J-18808-Ljbffr