Cleanroom Packaging Technician

BiVACOR Inc • Huntington Beach, CA

13d • Onsite

About The Position

The Cleanroom Packaging Technician is a hands-on role responsible for the packaging, labeling, and preparation of Class III medical devices for sterilization and distribution in compliance with documented procedures, quality standards, and regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 11607). This role requires precision, a quality-first mindset, and strict adherence to cleanroom protocols. This hands-on role contributes to the advancement of BiVACOR's innovative cardiovascular technology, requiring attention to detail and a commitment to patient safety.

Requirements

• High school diploma or equivalent required
• Minimum 1–2 years of experience in a cleanroom or regulated manufacturing environment, preferably medical devices or pharmaceuticals
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and GMP/GDP requirements
• Strong attention to detail and ability to follow written procedures precisely
• Fine motor skills required for handling delicate components and packaging materials
• Ability to read and accurately complete batch records and production documentation
• Strong verbal and written communication skills
• Ability to sit and/or stand for extended periods of time as needed
• Capability to lift and move up to 25 lbs when needed
• Willingness to wear full cleanroom attire (gown, gloves, mask, bouffant, etc.) for entire shifts
• Ability to work overtime as required

Nice To Haves

• Associate's degree or technical certification preferred

Responsibilities

• Package, label, and inspect finished medical device components and assemblies in accordance with approved work instructions and SOPs
• Maintain sterile barrier integrity throughout the packaging process in compliance with ISO 11607
• Complete production records, batch documentation, and device history records (DHRs) accurately and in real time
• Perform in-process quality inspections and communicate any non-conformances or quality concerns promptly
• Dispose of hazardous and controlled waste materials in designated areas per facility protocols
• Maintain cleanroom compliance including gowning, housekeeping, and environmental monitoring requirements
• Support packaging process validations, qualifications, and continuous improvement initiatives
• Maintain training proficiency and certifications to remain in compliance with GMP and GDP requirements
• Collaborate with Manufacturing, Quality, and Engineering teams to support daily production goals

Benefits

• Competitive compensation package
• 401(k) with company matching
• Medical, dental, and vision insurance
• Health Savings Account (HSA) & Flexible Spending Account (FSA)
• Life insurance & Employee Assistance Program
• Generous paid time off
• Discretionary annual bonus may be available based on individual and Company performance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED