Manufacturing Operator

Responsibilities

• Production
• Executes the process of assembly, filling, labeling & packaging equipment of varying complexity and in accordance with production manufacturing records, operating procedure requirements to produce finished intermediates and final kits while meeting production targets.
• Performs basic transactions within highly complex systems and controls in a regulated manufacturing environment (e.g., receive, process, build product/materials, facilitate material availability, SA transactions/confirmations).
• Runs automated systems/equipment and sequences of operation, including: equipment setup, operation, and cleaning; monitoring and performing basic troubleshooting.
• Participates in the execution of protocol/validations.
• Maintains the ability to be a subject matter expert (SME) in one or more areas of production.
• Contributes to daily end-of-shift reports and pass-downs.
• Safety and Quality
• Maintains Right to Operate and ensures that all processes are performed in a safe and healthy manner.
• Addresses and escalates any potentially unsafe hazards; Provides feedback during the investigation of safety hazards, incidents, and near misses using safety reporting tools.
• Performs tasks/transactions in the quality system to ensure we achieve our quality objectives.
• Understands the expectations of audit readiness (OSHA, FDA, QSR, GMP, ISO, etc.); may be required to answer questions about processes on the spot.
• Maintains accurate and complete system transactions, ensuring material traceability and inventory accuracy (e.g., receipt, storage, issuance of materials, and other inventory transactions).
• Provides feedback on NCR investigations, reworks, and corrective actions.
• Adheres to 95% or above internal training compliance
• Continuous Improvement
• Performs 6S activities, gathers/meets cycle times and develops/follows standard work; identifies and implements process improvements and continuous improvement initiatives utilizing lean tools.
• Participates and contributes in tier meetings.
• May participate in the collection of data for daily metrics purposes and to support operational excellence initiatives and improvements.
• Teamwork and Collaboration
• Proactively collaborates with peers in other shifts/functions to ensure daily targets are achieved.
• Assists in the successful onboarding of new employees and contractors.
• Other duties as assigned by management.

Requirements

• Formal Training/Education
• Education Level Education Details Req Pref
• H.S. Diploma Or GED. Req
• 2 years Relevant work experience in GMP environment
• Experience with automated manufacturing
• equipment in a regulated environment.
• Experience with validated software systems used to
• Maintain Quality, Inventory, and Processes.
• Familiarity with sensors, motors, cylinders, etc., and with the use of hand tools and test equipment.
• Knowledge, Skills, and Abilities
• Demonstrated experience with Lean / Continuous Improvement.
• Experience with Google products (gMail, gSheets, gDoc, etc).
• Experience with SAP.
• Ability to read, w

Benefits

Additional Information

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position The Manufacturing Operator contributes to producing reliable products and supplies with effective operations in an empowered organization. As part of a dynamic team, the Manufacturing Operator is responsible for collaborating with their team to operate automated equipment and systems to perform a wide variety of complex tasks related to assembly, printing, filling, and kitpack manufacturing operations. Recognizes and elevates safety, equipment, and product problems, contributing to the achievement of production goals. Utilizes validated software and systems to maintain processes, batch records, and inventory control. Ensures all production-related documentation is in compliance with quality system regulations. May be responsible for low complexity training of new employees and sharing best practices. They must have good communication and organizational skills and the ability to identify opportunities that would drive the business forward. This is an essential position supporting the organizational goals requiring attendance on weekends, holidays, and during emergency or exceptional conditions.

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