Job Title: Cleaning Validation Engineer (CIP & Execution Specialist)
Location: RTP, NC
Shift: Primarily Day Shift; potential for Night Shift

Job Summary:
Seeking an experienced Cleaning Validation SME to lead CIP processes, execute cleaning validation protocols, and manage large equipment cleaning in a biopharmaceutical environment. Expertise in MACO calculations, method validation, and compliance with regulatory standards is essential.

Key Responsibilities:

• Lead CIP cycle development and cleaning validation for bioreactors, tanks, and ancillary systems.
• Perform MACO assessments and execute validation protocols (IOQ/PQ).
• Collaborate with cross-functional teams on cleaning strategies and troubleshooting.
• Conduct method validation (e.g., swab and rinse sampling).
• Ensure cGMP compliance and support regulatory audits.

Qualifications:

• Bachelor's degree in Engineering, Biotechnology, or Chemistry.
• 5+ years of cleaning validation experience with CIP and large-scale equipment.
• Expertise in MACO calculations and validation documentation.
• Knowledge of biopharmaceutical manufacturing and regulatory standards.
• Strong problem-solving and technical writing skills.

Preferred:

• Experience with automated cleaning systems and process validation.
• Familiarity with cross-contamination control strategies.