Manufacturing Operator II (Microspheres)

Cordis; Irvine (CA); On-site; USD 52,000 - 56,000; Full time

Job summary

Cordis in Irvine, CA, is seeking a Manufacturing Operator II (Microspheres) to support preparation, mixing, inspection, filtration, and documentation for drug-loaded polymer microspheres under GMP. This role operates in a cleanroom environment to ensure product quality and regulatory compliance.

Key duties include running mixers and equipment, completing batch records, performing in-process inspections, line clearance, and packaging, with emphasis on accuracy, safety, and traceability.

Qualifications

• High-school diploma or equivalent.
• Minimum 2 years of experience in a regulated manufacturing environment, preferably medical devices.
• Proficiency in reading and following manufacturing instructions and drawings.
• Attention to detail, manual dexterity, and visual acuity for small-part assembly.
• Basic computer skills for data entry and documentation.
• Adequate eyesight to ensure effective inspection of product, labeling and packaging.
• Fluent in English.

Responsibilities

• Prepare solutions and materials.
• Operate mixers, jacketed tanks, and related equipment.
• Perform in-process inspections and documentation.
• Complete batch records and control documentation.
• Follow line clearance, cleaning, PPE, and safety requirements.
• Escalate deviations or out-of-spec results to supervision/engineering.
• Product packing and sterilization preparation.
• Document production activities in manufacturing lot history records.

Skills

Attention to detail

Teamwork

English fluency

Basic computer skills

Manual dexterity

Reading manufacturing instructions

Education

High-school diploma

Tools

QMS/ERP platforms

Job description

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

The Manufacturing Operator II (Microspheres) supports the preparation, mixing, inspection, filtration, and documentation of solutions used in the production of drug-loaded polymer microspheres. This role performs controlled manufacturing activities following approved Manufacturing Instructions, work instructions, and GMP requirements to ensure product quality, safety, and compliance.

Key Responsibilities

• Prepare solutions (weighing, mixing, heating, cooling, sampling, filtration)
• Operate mixers, jacketed tanks, TCU, peristaltic pumps, ultrasonic baths, bottle rollers, balances
• Perform in-process inspections and environmental controls
• Complete batch records and control documentation accurately
• Follow line clearance, cleaning, PPE, and safety requirements
• Escalate deviations or out-of-spec results to supervision/engineering
• Operating machinery to produce medical devices to meet the specifications.
• Following manufacturing instructions and updating the relevant job documentations accurately for traceability.
• Product packing and sterilization preparation.
• Product inspection using microscope.
• Perform setup, verification of, and teardown of equipment before and after processing.
• Prepare solutions and production materials.
• Perform manufacturing tasks, including fabrication, in-process testing, and packaging.
• Document production activities in manufacturing lot history records.
• Clean up production equipment and production area.
• Perform analysis of data (as needed)
• Troubleshoot product/process related issues.
• Work with chemicals and powders in a lab environment.
• Other duties may be assigned

Qualifications

Required Qualifications

• High-school diploma or equivalent.
• Minimum 2 years of experience in a regulated manufacturing environment, preferably medical devices.
• Proficiency in reading and following manufacturing instructions and drawings.
• Strong attention to detail, manual dexterity, and visual acuity for small-part assembly.
• Basic computer skills for data entry and documentation.
• Adequate eyesight to ensure effective inspection of product, labeling and packaging. (Use of corrective lenses is acceptable).
• Ability to work with potentially hazardous chemicals and safe handling of chemicals
• Ability to work overtime and/or weekends, according to business need.
• Fluent in English.

Preferred Qualifications

• Experience with drug-coated balloons or catheter production.
• Experience with solution preparation, filtration, and sampling
• Familiarity with cleanroom/controlled environments
• Familiarity with cleanroom protocols and quality documentation systems (e.g., QMS or ERP platforms).

Key Competencies

• Dependable, punctual, and quality-focused.
• Excellent teamwork and communication skills.
• Ability to multitask and maintain accuracy under time constraints.
• Positive, solution-oriented attitude toward process improvement.
• Commitment to safety, cleanliness, and regulatory compliance.

Working Conditions

• Cleanroom and controlled manufacturing environment.
• Standing and/or sitting for extended periods.
• Frequent use of microscopes, small tools, and measuring equipment.
• Light lifting (up to 25 lbs.).
• Must wear required PPE and adhere to EHS policies.

Pay / Compensation

The expected pre-tax pay rate for this position is $26.00 per hour. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location. US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Preferred Qualifications

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammates' points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.