Production Operator

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 32,000 - 42,000; Full time

Job summary

Otsuka ICU Medical LLC in Austin, TX seeks a production associate to execute repetitive fabrication and sterilization tasks following SOPs. You will document operations, perform line clearances, and assist with cleaning within a cGMP environment.

The role requires basic math, strong teamwork, and clear communication. Training on GMP and safety is provided; expect shifts and a production-line setting.

Qualifications

• Must accurately follow verbal and written instructions.
• Ability to perform basic mathematical calculations (add, subtract, multiply, divide, percentages).
• Identify issues and solve problems in a manufacturing setting.
• Work respectfully in a teamwork-driven environment.
• Effective communication with team members and leads.
• GMP awareness and ability to obtain area certifications.

Responsibilities

• Perform repetitive tasks per SOPs and meet production standards.
• Document work in batch records and other official documents accurately.
• Conduct lot changes, line clearances, and cleaning operations.
• Inspect materials and processes for inconsistencies and report promptly.
• Collaborate with team to coordinate activities and communicate effectively.
• Adhere to cGMP guidelines and Job Safety Analysis (JSA).
• Make minor equipment adjustments and troubleshoot issues.

Skills

Follow verbal & written instructions

Basic math calculations

Problem solving

Teamwork

Effective communication

GMP awareness

Education

HS diploma or equivalent

English proficiency

18+ years old

Job description

Dept: 1274 - Irr Sterilization

• Performs a variety of consistent repetitive tasks and other activities as specified in standard operating procedures (SOPs).
• Responsible for achieving production standards in manual operations and/or while operating equipment.
• Responsible for following safety, quality, compliance, and company policies and practices.
• Responsible for accurate and timely documentation of work in batch records, logbooks, and other official documents.
• Perform and document lot changes, line clearances, production processes and cleaning operations.
• Inspect, identify, and communicate any inconsistencies of materials, commodities, product, process, or equipment in a timely manner
• Work in a team environment to coordinate activities, solve problems, and effectively communicate.
• Remain flexible and adaptable to change.
• Adhere to current Good Manufacturing Practices (cGMP) regulatory guidelines, and Job Safety Analysis (JSA).
• Ability to perform minor adjustments, clear jams, evaluate products within specified limits and troubleshoot equipment.
• Perform other duties as assigned or required.

Job Description

• Performs a variety of consistent repetitive tasks and other activities as specified in standard operating procedures (SOPs).
• Responsible for achieving production standards in manual operations and/or while operating equipment.
• Responsible for following safety, quality, compliance, and company policies and practices.
• Responsible for accurate and timely documentation of work in batch records, logbooks, and other official documents.
• Perform and document lot changes, line clearances, production processes and cleaning operations.
• Inspect, identify, and communicate any inconsistencies of materials, commodities, product, process, or equipment in a timely manner
• Work in a team environment to coordinate activities, solve problems, and effectively communicate.
• Remain flexible and adaptable to change.
• Adhere to current Good Manufacturing Practices (cGMP) regulatory guidelines, and Job Safety Analysis (JSA).
• Ability to perform minor adjustments, clear jams, evaluate products within specified limits and troubleshoot equipment.
• Perform other duties as assigned or required.

Reports to: Eladio Perez

Dept: 1274 - Irr Sterilization

Shift: 3rd - Sunday - Thur, 9:30pm - 6:00am

Essential Duties & Responsibilities

• Performs a variety of consistent repetitive tasks and other activities as specified in standard operating procedures (SOPs).
• Responsible for achieving production standards in manual operations and/or while operating equipment.
• Responsible for following safety, quality, compliance, and company policies and practices.
• Responsible for accurate and timely documentation of work in batch records, logbooks, and other official documents.
• Perform and document lot changes, line clearances, production processes and cleaning operations.
• Inspect, identify, and communicate any inconsistencies of materials, commodities, product, process, or equipment in a timely manner
• Work in a team environment to coordinate activities, solve problems, and effectively communicate.
• Remain flexible and adaptable to change.
• Adhere to current Good Manufacturing Practices (cGMP) regulatory guidelines, and Job Safety Analysis (JSA).
• Ability to perform minor adjustments, clear jams, evaluate products within specified limits and troubleshoot equipment.
• Perform other duties as assigned or required.

Knowledge & Skills

• Must accurately follow both verbal and written instructions.
• Ability to perform and document basic mathematical calculations, (e.g. add, subtract, multiply, divide, work with fractions, decimals and percentages).
• Must be able to identify issues and solve problems.
• Must be able to work respectfully in a team environment.
• Must be able to communicate effectively.
• Must be able to pass the Good Manufacturing Practices (GMP) test and obtain required area certifications.

Minimum Qualifications, Education & Experience

• High School education or equivalent required. Two years of verifiable Manufacturing experience may be substituted for a HS diploma.
• Must be at least 18 years of age
• Ability to read, write, understand, and communicate in English.

Work Environment

• Typically requires travel less than 5% of the time
• Varying levels of physical activity based on specific assignment including standing, sitting, stooping, lifting, and fine motor skills with hands
• Consistent, repetitive tasks while on the production line.
• Must wear hearing protection, safety shoes, Safety Glasses, prescription glasses (if prescribed), and any/all personal protective equipment (PPE) required to perform jobs in assigned areas.
• Must be comfortable wearing complete (head to toe) gowning material.
• No forms of jewelry including rings, necklaces, earrings, and any other piercings, are allowed in the production areas except a Medical Alert neck chain.
• Cosmetics, lash extensions, artificial nails, nail polish, nail enhancer, or any type of nail coating(s) cannot be worn in production areas.
• May be required to work outside and its elements, to assist with material disposition.
• Must be able to lift up to 35 lbs. unassisted and up to 75 lbs. assisted.

About Us

Innovation, Impact, and Purpose.

Find Your Future Here.

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption.

When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.

We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.

Join us and help shape the future of IV solutions.

EEO Statement

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

Otsuka ICU Medical CCPA Notice to Job Applicants