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EDUCATION:

• Minimum of a Bachelor’s / University or equivalent degree is required; an Engineering degree is strong desired, preferably from an accredited college or university

• Perform CQV activities for cleanroom areas and large process equipment, including but not limited to: Vessels (Bioreactors, Fermenters, Mixing Tanks); Centrifuges; Pharma Dryers; and/or CIP (Clean-in-Place) Skids.
• Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Generate and maintain validation documentation, including final reports ensuring compliance with GMP, FDA, and industry standards.
• Work closely with engineering, quality, and operations teams to troubleshoot validation challenges and implement corrective actions.
• Support regulatory audits and inspections by providing validation documentation and justifications.
• Ensure compliance with cGMP, 21 CFR Part 11, ISPE Baseline Guides, and ASTM E2500 methodologies.
• Assist in risk assessments, change control evaluations, and impact assessments for equipment modifications.