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We are looking for a Machine Operator I to support routine manufacturing and production activities in a regulated environment. The role involves operating production equipment, maintaining quality standards, completing documentation, and working closely with technicians and team leads to meet production and quality goals.
Job Responsibility:
Perform routine production tasks including filling, packing, packaging, assembling, labeling, and inspection
Operate production equipment under general supervision
Conduct in-process quality checks and ensure product quality standards are met
Accurately complete and maintain documentation in compliance with FDA, GMP, and ISO 9000
Assist with product and equipment changeovers
Support equipment troubleshooting, minor repairs, and preventive maintenance
Maintain cleanliness of machines, work areas, and floors
Record production data including PPH, scrap/waste, SAP, and MES transactions
Identify and report production or quality issues to the Cell Lead
Participate in continuous improvement (CI) activities such as Kaizen, Blitz, and KAS
Work collaboratively with team members to ensure smooth shift handovers
Support business needs by working overtime or flexible hours when required
Perform other assigned duties as needed
Requirements:
Manufacturing or industrial experience – required
Experience in regulated environments is preferred
Prior machine operation experience is an advantage
Ability to read, write, and communicate clearly in English (mandatory)
Basic math skills
Attention to detail and quality-focused mindset
Ability to follow standard operating procedures (SOPs)
Teamwork and collaboration skills
Problem-solving and willingness to learn
Ability to work in a fast-paced production environment
High School Diploma or GED (preferred)
Background check clearance – mandatory
Must be legally eligible to work in the USA
Willingness to work flexible or extended hours
Ability to rotate across different tasks and responsibilities
Reliable, punctual, and able to work consistently
Nice to have:
Experience in regulated environments is preferred
Prior machine operation experience is an advantage