Sterile Packaging & Cleanroom Lead

Cleanroom Operations & Sterile Packaging Technician

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 Technician, 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:

• 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.

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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