Pharmaceutical Qualification Expert

3 days ago


Chicago, Illinois, United States Sterling Engineering Inc. Full time

About This Role:

We are seeking an experienced Pharmaceutical Qualification Expert to join our team at Sterling Engineering Inc.

Job Summary:

The successful candidate will be responsible for ensuring the qualification and validation of our equipment and facilities to meet regulatory requirements.

Responsibilities:

  1. Develop and execute qualification plans for equipment and facilities
  2. Perform risk assessments and validate equipment and systems to ensure compliance with 21 CFR Part 210 and 211
  3. Collaborate with cross-functional teams to develop and implement commissioning plans and procedures
  4. Provide technical support and guidance to maintenance personnel and other stakeholders
  5. Document and track qualification activities using standardized templates and procedures

Preferred Skills and Qualifications:

  • Bachelor's or Master's degree in Engineering, Science, or a related field
  • 3+ years of experience in pharmaceutical quality assurance and control
  • Experience working in a regulated industry such as pharmaceuticals or medical devices

Benefits:

  • Competitive salary range: $90,000 - $120,000 per year
  • Comprehensive benefits package including health insurance, retirement plan, and paid time off
  • Ongoing training and professional development opportunities


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