Production Operator

Otsuka ICU Medical; Austin (TX); On-site; USD 25,000 - 36,000; Full time

Job summary

Otsuka ICU Medical in Austin, TX is seeking a production operator to perform line and material handling tasks in a manufacturing environment. You will work to meet standard production rates, follow safety and cGMP guidelines, and document work accurately in batch records and SOPs.

You will participate in area improvements, coordinate with team members, and adapt to changes while wearing required PPE. The role requires basic mechanical aptitude, English communication, and the ability to lift up

Qualifications

• High School education or equivalent.
• Must be at least 18 years old.
• Ability to read, write, and communicate in English.
• Ability to perform basic mathematical calculations.

Responsibilities

• Inspect components, materials, documents, and final products either as part of the production process or offline.
• Performs activities specified in batch records and SOPs.
• Identify non-conforming product and notify area supervisor if out of limits.
• Perform and document lot changes, line clearances, production processes and cleaning operations.
• Adhere to cGMP guidelines, SOPs and plant policies/rules.

Skills

English literacy

Basic math

Mechanical adjustments

Troubleshooting equipment

GMP compliance

Education

High School diploma or equivalent

Job description

Job Description Position Summary

Performs any one or combination of production line and material handling in manufacturing. Responsible for achieving production standards in manual operations and/or while operating equipment requiring average mechanical skills and aptitude. Responsible for achieving standard production rates, following safety, compliance, and company policies and practices. Responsible for accurate and timely documentation of work in batch records, logbooks and other official documents.

Essential Duties & Responsibilities

• Inspect components, materials, documents and final products either as inherent part of the production process or offline.
• Performs activities specified in batch record and SOP’s.
• Sample and evaluate product per defined methods, recognizes action levels and notifies area specialist and supervisor if out of limits.
• Perform and document lot changes, line clearances, production processes and cleaning operations.
• Identify non-conforming product (rejects).
• Achieve established labor standards for the respective tasks.
• Provide information and feedback on commodity and process issues.
• Ensures quality products are delivered to subsequent processes.
• Work in a team environment to coordinate activities, solve problems and effectively communicate.
• Adapt to changes in a constructive manner.
• Participation in area improvements, cost reductions, and meetings.
• Provide information and feedback on commodity and process issues.
• Ensures quality products are delivered to subsequent processes.
• Adhere to cGMP guidelines, SOP’s and plant policies/rules.
• All other duties as deemed necessary by supervisor or manager.
• Able to evaluate process, product and equipment performance based on prescribed procedures.
• Work with team members to reach consensus to optimize quality, cost, compliance, customer service and safety.
• Perform other related duties as assigned or required, to include working in the outside elements for material disposition.

Knowledge & Skills

• Ability to read, write, understand and communicate in English.
• 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).
• Ability to perform minor mechanical adjustments, clear jams, evaluate product within specified limits and troubleshoot equipment.
• Must be able to pass the GMP test and obtain area certifications.

Minimum Qualifications, Education & Experience

• High School education or equivalent required.
• Must be at least 18 years of age

Work Environment

Typically requires travel less than 5% of the time. This position is required to ensure production standards are met. Varying levels of physical activity based on specific assignment. Must wear hearing protection, safety shoes, prescription glasses (if prescribed), and any/all personal protective equipment (PPE) required to perform jobs in assigned 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

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Otsuka ICU Medical CCPA Notice to Job Applicants