Senior Quality Engineer Specialist - Pharmaceutical

Senior Quality Engineer Specialist

Location: Sanford, NC

Pay Rate: $60 - $66 per hour DOE

Growing pharmaceutical company located in Sanford, NC is in need of a Senior Specialist, Quality Engineer to join the team! This individual will be a key member of the Quality Systems & Compliance and drives GMP-compliant startup of equipment, utilities, facilities, and DS processes. The role validates, verifies, and confirms readiness of assets and processes and ensures data integrity controls are embedded across validation and operations.

Duties

• Provide Quality oversight for GMP readiness during facility startup, including equipment, utilities, facilities, and process validation
• Review and approve qualification and validation deliverables for DS manufacturing systems
• Confirm system readiness by reviewing evidence such as drawings, P&IDs, and turnover packages to verify fitness for intended use
• Support development and review of Preventive Maintenance (PM) and calibration programs, including intervals and criticality assessments
• Execute and/or lead change controls, risk assessments, and investigations (e.g., FMEA, hazard analysis)
• Drive structured problem-solving related to equipment, utilities, facilities, calibrations, and PMs
• Ensure compliance with data integrity requirements, 21 CFR Part 11, and ALCOA principles
• Partner closely with Engineering, Validation, Maintenance, Automation, Manufacturing, and QC teams
• Maintain inspection-ready documentation and asset status throughout startup activities
• Other duties as assigned
  
  

Requirements:

• Bachelor's degree in relevant field
• 5 years of experience in GxP regulated environment with a focus on Quality Engineering
  
  

Zing Recruiting, a leader in the staffing industry for the past 33 years, continues our vision of ‘linking’ communities through employment. Zing's dedication to the safety, health & well-being of our associates, clients and communities remains our #1 priority. Zing is proud to be an EEOE, M/F/D/V, and we are committed to diversity both in practice and spirit at all levels of the organization.

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