Senior Manufacturing Operator, 1st Shift M

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Senior Manufacturing Operator performs post-formulation processing such as product cutting, inspection, defect identification, packaging, machine packaging operations, labeling, and boxing in order to produce the finished good. Also performs sub assembly post chemical processing such as crosslinking required to produce collagen-based products. All work streams include responsibility in the setup, operation and cleaning of all cleanroom manufacturing equipment. All chemical processing operations are performed in ISO Class 5 or ISO Class 7 areas and require proper Cleanroom gowning.

All processing is performed in compliance with Good Manufacturing Practices, Quality Systems Regulations, Standard Operating Procedures and Health and Safety requirements. Operates in a team environment focused on daily milestones and quality throughout.

• Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and be able to make minor equipment adjustments as needed.
• Subject Matter expert on processes and procedures.
• Perform precise measurements and use measurement equipment to accurately add chemicals to batches.
• Crosslinking, cutting, packaging, and boxing of the product in its finished goods form, including visual product and component inspections to identify and remove defects.
• Pass and maintain gowning qualification to perform gowning requirement for ISO Class 5 or ISO Class 7 cleanroom operations.
• Accurately maintain legible and accurate records, required logs, books, records, and other procedures to comply with regulatory requirements, GMP, Quality Systems Regulations, SOPs, and Health and Safety requirements.
• Interface with QA/QC/Material Management departments during work to coordinate inspections and efficient flow of subassemblies and completed product.
• Enter and record production activities in Oracle MRP systems to issue material and labor hours to specific work orders.
• Regularly train colleagues with less experience with the area Supervisor, Lead Operator, or Training Lead.
• Follow applicable SOPs, Quality System Regulations, and ISO 13485 requirements.

• High School diploma or equivalent. Degree in a related science a plus.
• Minimum of 5 years of production experience and/or chemical processing experience and/or batch mixing in medical device or pharmaceutical manufacturing industry.
• Basic computer skills for email and data entry.
• Must read, write, and speak in English, and communicate clearly and concisely.
• Fundamental understanding of mathematics and chemistry.
• Able to participate in a team-oriented environment, willingness to assist and train others.
• Able to work independently with minimal supervision.
• Ability to operate, maintain and troubleshoot process equipment, and make minor adjustments as needed.
• Ability to gown to ISO Class 5 and 7 cleanroom standards.
• Able to work overtime.
• Support department and plant safety goals by continuously demonstrating safe behavior.
• Maintain a clean and orderly work area.
• Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements.
• Perform other manufacturing activities as assigned by the department leadership.
• Requires proficiency through job-related training and considerable on the job experience.
• May act as an informal resource for colleagues with less experience.

Lyophilizers, Autoclave, homogenizers, grinder, vacuum pump, pH meters, thermometers, balances, water bath circulators, sonicators, humidity cabinet, mixers, centrifuge, blenders, air gun, drop indicator, filamat filling machines, slicer machines, scalpels, temperature recorders, crosslinking chamber, humidification chamber, compression unit, cutting table, sealing machines, shrink wrap…