Manufacturing Operator
Onsite Position - Local Candidates
San Jose, CA
Standard Shift: 8-5pm
Description:
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, in-line testing, cleaning and packaging manufacturing operations.
Manufacturing Operator 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.
Responsibilities:
Production (80%)
Executes the process of assembly in-line testing, cleaning and packaging of varying complexity and in accordance with production manufacturing records, operating procedure requirements to produce finished intermediates and final kits while meeting production targets.
Capable of basic transactions within highly complex systems and controls in a regulated manufacturing environment (e.g. receive, process, build product/materials, facilitate material availability, SAP transactions/confirmations).
Runs automated systems/equipment and sequences of operation, including: equipment setup, operation, and cleaning; monitoring and performing basic troubleshooting.
Participate in the execution of protocol/validations.
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 (10%)
Maintain Right to Operate and ensure that all processes are performed in a safe and healthy manner; Address and escalate any potentially unsafe hazards; Provides feedback during investigation of safety hazards, incidents and near misses using safety reporting tools.
Perform tasks/transactions in the quality system to ensure we achieve our quality objectives.
Understand the expectations of audit readiness (OSHA, FDA, QSR, GMP, ISO, etc.); may be required to answer questions about processes on the spot.
Maintain accurate and complete system transactions ensuring material traceability, and inventory accuracy (e.g. receipt, storage, issuance of materials, and other inventory transactions)
Provide feedback on NCR investigations, reworks, and corrective actions.
Adhere to 95% or above internal training compliance
Continuous Improvement (5%)
Responsible for 6S activities, gathering/meeting cycle times and developing/following 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 (5%)
Proactively collaborates with peers in other shifts/functions to ensure daily targets are achieved.
Assist in the successful onboarding of new employees and contractors.
Education/Experience:
High School Diploma/GED, required
Associates Degree (preferred)
2 years relevant work experience, preferably in GMP environment
Experience with automated manufacturing equipment in a regulated environment, required.
Experience with validated software systems used to maintain Quality, Inventory, and Processes, required.
Familiarity with use of hand tools and test equipment, required.
Knowledge Skills and Abilities :
Demonstrated experience with Lean / Continuous Improvement
Experience with Google products (gMail, gSheets, gDoc, etc), preferred
Experience with SAP required.
Regards,
Lakshmi
