Cleanroom Operations & Sterile Packaging SupervisorSalary Range: $90,000 - $100,000 annually Location: West Chester, PA
Industry: Medical Device Manufacturing
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 ForRequired 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.
