Manufacturing Operator II (Microspheres)

Manufacturing Operator II (Microspheres)

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.

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

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
• 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.