Sterile Packaging & Cleanroom Supervisor

Job Description

Job Description

Cleanroom Operations & Sterile Packaging Supervisor

Salary Range: $90,000 - $100,000 annually

Location: West Chester, PA
Industry: Medical Device Manufacturing

Help Build Medical Devices That Improve Lives

Are you passionate about quality, precision, and working in a highly regulated manufacturing environment? Join our team as a Cleanroom Operations & Sterile Packaging Supervisor , where you'll play a critical role in the final assembly, inspection, cleaning, and sterile barrier packaging of life-changing medical devices.

This position is ideal for someone with cleanroom experience who thrives in a detail-oriented environment and takes pride in producing products that directly impact patient care.

What You'll Do

As a member of our Cleanroom Operations team, you will:

• Lead and perform all cleanroom activities from the bench up: hands-on production, ISO Class 7 requalification, calibration of supporting cleanroom equipment and systems, environmental monitoring, excursion investigation and documentation, and routine bioburden analysis for the sterile barrier system process.
• Perform final assembly of medical devices following detailed work instructions and engineering drawings.
• Clean and prepare medical devices using validated cleaning processes.
• Conduct visual and dimensional inspections to ensure products meet strict quality standards.
• Package products using validated sterile barrier systems, including pouches and trays.
• Operate heat-sealing equipment and verify seal integrity.
• Apply labels, lot numbers, expiration dates, and regulatory markings accurately.
• Complete ERP transactions and maintain complete product traceability.
• Document batch records, inspections, and quality activities.
• Identify and report non-conforming products.
• Monitor cleanroom environmental conditions and support routine preventive maintenance activities.
• Assist with process improvements, equipment qualifications (IQ/OQ/PQ), validations, and new product/process transfers.
• Support internal audits and maintain compliance with FDA and ISO quality requirements.

What We're Looking For

Required Qualifications

• High school diploma or equivalent with 5+ years of leadership or hands-on experience in a cleanroom environment , OR
• Bachelor's degree with 2+ years of related technical experience.
• Strong attention to detail and documentation accuracy.
• Ability to follow written procedures and work in a controlled cleanroom environment.

Preferred Qualifications

• Experience in medical device, pharmaceutical, biotechnology, or another regulated manufacturing environment.
• Previous sterile barrier packaging experience.
• Knowledge of ISO 11607, ASTM packaging standards, or gamma sterilization processes.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and ISO 14644.
• Cleanroom operations or sterile processing certification is a plus.

Why Join Us?

• Work on products that improve patients' lives around the world.
• Be part of a growing, quality-focused medical device manufacturer.
• Collaborative team environment with opportunities to support process improvements and validation projects.
• Stable, clean, and professional manufacturing environment.
• Opportunities for professional growth and continued learning.

Why You'll Love Working Here

• Competitive compensation based on experience
• Overtime opportunities available
• State-of-the-art climate-controlled manufacturing facility
• 100% paid uniforms
• Multiple health insurance plans, including no-cost HAS options for eligible employees
• Dental and vision coverage
• 401 (k) with employer match
• 100 hours of PTO during your first year
• 7 paid holidays annually
• Employee Assistance Program (EAP)
• Wellness Coach Program access
• Stable, long-term career opportunities within a growing medical device manufacturer

If you're someone who values precision, quality, and making a meaningful impact through your work, we'd love to hear from you. Apply today and help us deliver innovative medical devices that make a difference.

Acero Precision is proud to be an Equal Opportunity Employer. Acero Precision does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need.

*Principals only. Recruiters please do not apply on behalf of your candidates to Acero Precision job posts. All applications and/or contact information submitted are kept on file and are the property of Acero Precision. Please note recruiting fees will not be honored with candidate applications submitted by recruiters.

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