Sterile Packaging & Cleanroom Supervisor

Acero Precision; West Chester (Chester County); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health insurance plans

401(k) with employer match

Paid time off (100 hours first year)

7 paid holidays

Uniforms provided

EAP (Employee Assistance Program)

Wellness Coach Program

Job summary

Acero Precision in West Chester, PA is hiring a Cleanroom Operations & Sterile Packaging Supervisor to lead final assembly, cleaning, and sterile packaging of life-saving medical devices. The role emphasizes precise documentation, adherence to procedures, and strict quality standards.

Ideal candidates have cleanroom leadership experience with strong attention to detail and familiarity with regulated manufacturing environments. The position is on-site with competitive compensation and benefits.

Qualifications

• 5+ years in a cleanroom leadership or hands-on role.
• Bachelor's degree with 2+ years related technical experience.
• Strong attention to detail and documentation accuracy.
• Ability to follow written procedures in a controlled cleanroom environment.

Responsibilities

• Lead and perform all cleanroom activities from the bench up: production, ISO Class 7 requalification, equipment calibration, environmental monitoring, and documentation.
• Perform final assembly of medical devices following work instructions and engineering drawings.
• Clean and prepare medical devices using validated cleaning processes.
• Conduct visual and dimensional inspections to ensure quality.
• Package products using validated sterile barrier systems and verify seal integrity.
• Complete ERP transactions and maintain complete product traceability.

Skills

Cleanroom leadership

Documentation accuracy

Attention to detail

Regulatory compliance

Education

High school diploma or equivalent

Bachelor's degree with 2+ years related technical experience

Job description

Job Category : Quality

Requisition Number : STERI002077

• Posted : July 28, 2026
• Full-Time
• On-site

Locations

Showing 1 location

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.
• 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.

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.

Make Our Mission Your Mission!

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.