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.
Make Our Mission Your Mission!
Pay: $90,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Opportunities for advancement
- Paid time off
- Professional development assistance
- Vision insurance
Application Question(s):
- Describe your hands-on experience working in a controlled cleanroom environment. Please include the ISO class(es) and industry (medical device, pharmaceutical, biotechnology, etc.).
- What were your responsibilities related to gowning, aseptic technique, and environmental monitoring? Please describe your role and any documentation or monitoring you performed.
- Have you performed heat-seal validation or seal-integrity testing (peel strength, visual inspection, dye penetration, or similar) under ASTM F88 or equivalent standards? If yes, describe an example.
- This role requires ownership of and training to aseptic techniques. Describe a time you had to enforce a procedure or correct a peer/trainee.
- This position requires working fully gowned in a controlled cleanroom environment for extended periods, occasionally lifting up to 10 lbs., and traveling up to 5% of the time. Are you able to meet these job requirements?
- Do you have an active or prior NDA/non-compete obligation with a current or former employer that could affect your eligibility for this role?
- If you are 45 minutes or farther from our facility, are you able/willing to relocate?
- What salary expectations do you have for this position?
Work Location: In person
