Quality Engineer

Job Description

Job Description

ATR International, Inc. cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar). Candidates must have valid U.S. work authorization.

Location: Frederick, MD (Onsite – 5 days a week)

Job Type: 1-Year Contract

Pay Rate: $26.28 - $36.28 / hour (Depending on experience)

Position Summary

We are seeking a detail-oriented Quality Engineer to join a leading, world-class biopharmaceutical organization in Frederick, MD. In this role, you will provide critical Quality oversight and guidance for cGMP Work Orders and Equipment Monitoring System (EMS) alarms. This position ensures the integrity of critical equipment, facilities, and utilities required for both commercial and clinical production.

If you thrive in a fast-paced, cutting-edge scientific environment and have a strong background in FDA-regulated compliance, we want to hear from you!

Key Responsibilities

• Quality Oversight: Provide guidance and oversight for all cGMP Work Orders performed on critical equipment, facilities, and utilities necessary for production.
• Alarm Resolution: Monitor and provide resolution guidance for all alarms generated by the Equipment Monitoring System (EMS).
• Cross-Functional Collaboration: Partner with manufacturing, engineering, product development, QC, and supply chain teams to support CQV (Commissioning, Qualification, and Verification) and CSV (Computer System Validation) execution.
• Metrics & Risk Management: Track, review, and report quality metric information. Support broader Quality Engineering functions, including validation activities and quality risk management.
• Standards Expert: Demonstrate a deep working knowledge of pharmaceutical relevant standards, principles, and industry best practices.

Basic Qualifications

• Master’s Degree strictly in an Engineering discipline (Biomedical, Mechanical, or Chemical Engineering). Note: Pure life science, biology, or biotechnology degrees do not qualify for this entry-level tier.
• OR Bachelor’s Degree with 2+ years of experience in a pharmaceutical or FDA-regulated environment.
• OR Associate’s Degree (AA) with 4+ years of experience in a pharmaceutical or FDA-regulated environment.
• OR High School Diploma / GED with 5+ years of experience in a pharmaceutical or FDA-regulated environment.

Preferred Qualifications

• Systems Experience: Familiarity with cGMP maintenance/calibration planning and execution through a CMMS (e.g., BMRAM and/or Maximo) is a major plus.
• Building Management: Experience with building management systems (e.g., Siemens Desigo) is preferred.
• Industry Experience: Cell and Gene Therapy experience is a strong plus.
• Soft Skills: Strong critical thinking, troubleshooting, and problem-solving skills; excellent written and verbal communication; and the ability to work independently in a fast-paced, diverse environment.

Benefits & Perks

• Health & Wellness: Choose from comprehensive medical, dental, and vision insurance packages.
• Retirement Planning: Secure your future with a 401(k) retirement savings plan featuring an employer match (available after 1 year of employment).
• Financial Protection: Life and supplemental income insurance options are available to protect you and your family.
• Employee Perks: Access to exclusive commuter benefits, employee discount programs, and talent referral rewards.
• Paid Sick Leave: Accrued and provided in strict accordance with applicable state and local laws.

Note: Full benefits eligibility is open to all full-time employees working an average of 30 hours or more per week.

ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.

Company Description

ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.