Manufacturing Operator

Location : Santa Clara, CA

Hourly rate : $25.00 - $30.00

Hours : 8am to 5pm, This is an essential position supporting the organizational goals requiring attendance on some weekends, holidays and during emergency or exceptional conditions.

Contractor benefits : Medical, Vision, Dental, 401k

Summary :

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.

Education / Experience :

149; 2 years relevant work experience, preferably in GMP environment.

149; Experience with automated manufacturing equipment in a regulated environment, required.

149; Experience with validated software systems used to maintain Quality, Inventory, and Processes, required.

149; Familiarity with use of hand tools and test equipment, required.

Knowledge Skills and Abilities :

149; Demonstrated experience with Lean / Continuous Improvement.

149; Experience with Google products (gMail, gSheets, gDoc, etc), preferred.

149; Experience with SAP required.

149; Ability to read, write and comprehend English.

149; Ability to work with cross-functional teams.

149; Ability to be agile and accurate in a high-volume environment.

149; Strong organizational skills, planning skills and attention to detail.

149; Strong communication skills - written, verbal.

149; Strong critical thinking, problem solving and analytical skills.

149; Excellent time management skills to manage multiple tasks and competing timelines.

149; Ability to use the technology associated with the industry.

149; Ability to use precision tools.

149; Ability to have prompt, regular and reliable worksite attendance.

Responsibilities : Production (80%)

Production (80%)

149; Executes the process of assembly in-line testing, cleaning and packaging of varying complexity and in

149; accordance with production manufacturing records, operating procedure requirements to produce finished intermediates and final kits while meeting production targets.

149; Capable of basic transactions within highly complex systems and controls in a regulated manufacturing.

149; environment (e.g. receive, process, build product / materials, facilitate material availability, SAP

149; transactions / confirmations).

149; Runs automated systems / equipment and sequences of operation, including : equipment setup, operation, and cleaning;

monitoring and performing basic troubleshooting.

149; Participate in the execution of protocol / validations.

149; Ability to be a subject matter expert (SME) in one or more areas of production.

149; Contributes to daily end of shift reports and pass downs.

Safety and Quality (10%)

149; Maintain Right to Operate and ensure that all processes are performed in a safe and healthy manner.

149; Address and escalate any potentially unsafe hazards; Provides feedback during investigation of safety hazards, incidents and near misses using safety reporting tools.

149; Perform tasks / transactions in the quality system to ensure we achieve our quality objectives.

149; Understand the expectations of audit readiness (OSHA, FDA, QSR, GMP, ISO, etc.); may be required to answer questions about processes on the spot.

149; Maintain accurate and complete system transactions ensuring material traceability, and inventory accuracy (e.g. receipt, storage, issuance of materials, and other inventory transactions)

149; Provide feedback on NCR investigations, reworks, and corrective actions.

149; Adhere to 95% or above internal training compliance.

Continuous Improvement (5%)

149; Responsible for 6S activities, gathering / meeting cycle times and developing / following standard work.

149; identifies and implements process improvements and continuous improvement initiatives utilizing lean tools.

149; Participates and contributes in tier meetings.

149; May participate in the collection of data for daily metrics purposes and to support operational excellence initiatives and improvements.

Teamwork and Collaboration (5%)

149; Proactively collaborates with peers in other shifts / functions to ensure daily targets are achieved.

149; Assist in the successful onboarding of new employees and contractors.

149; Other duties as assigned.

Physical conditions and PPE requirements :

149; The physical demands described are representative of those that must be met by an individual to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

149; Required to stand, walk, sit, kneel, bend, crouch for a combined 8 or more hours per day.

149; Required to push, pull, and lift a minimum of 50 pounds. Repetitive, consistent movements of the wrists, hands, and / or fingers.

149; Required to have good near visual acuity to perform activities throughout the processes in the assigned area.

149; Must be able to work in, on, around, over and under fixed equipment and machinery; to work from lifts and ladders;

to manipulate heavy equipment, tools and supplies; to concurrently manipulate multiple controls and machinery; and to wear and work in personnel protective equipment.

149; Required to work and handle hazardous chemicals and adhere to all PPE Requirements.

Must be U.S. Person for purposes of Export Compliance.

Last updated : 2024-05-11