Quality Engineer

Key Responsibilities

• Ensure validation activities comply with cGMP, FDA regulations, ISO standards, and internal quality procedures.
• Develop, review, and approve validation documentation including Validation plans, Protocols (IQ, OQ, PQ), reports and summary documents.
• Support lifecycle management of validated systems and software, including requalification, change control, and periodic review.
• Provide guidance on risk-based validation strategies aligned with industry standards (e.g., GAMP, ICH Q9).
• Provide quality engineering support to analytical laboratories.
• Assist with equipment validation/verification and troubleshooting activities. Support laboratory equipment qualification and lifecycle management.
• Lead or participate in cross-functional quality improvement projects. · Drive initiatives related to process optimization, validation efficiency, and quality system improvements.
• Support implementation of new technologies, automation, or process changes requiring validation oversight.
• Provide technical expertise during new product introduction (NPI) or process transfer activities.
• Provide day-to-day quality engineering support to operations.
• Support deviation investigations, CAPA development, and root cause analysis. Participate in change control assessments, ensuring proper validation impact evaluation.
• Review and approve technical documentation related to manufacturing and quality systems.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place and maintained.

Qualifications

• Bachelor’s degree in Engineering (Chemical, Electrical or Mechanical) preferred
• Minimum of 5 years of experience in facilities, equipment, utilities and FDA regulated environment.
• Bonus Qualifications: PE or EIT, preferred