Job Description

LOA : 12 months

Shift: Primarily Day Shift; potential for Night Shift work in the future

Job Summary:

We are seeking an experienced Cleaning Validation Subject Matter Expert (SME) to lead and execute cleaning validation activities in a dynamic biopharmaceutical environment. This role focuses on Cleaning-In-Place (CIP) processes, cleaning validation execution, and large equipment cleaning strategies, including bio-reactors. The ideal candidate will bring expertise in cleaning validation, MACO (Maximum Allowable Carryover) assessments, and method validation, ensuring compliance with regulatory requirements and company standards.

Key Responsibilities:

• Lead cleaning validation activities, including CIP cycle development, execution, and optimization for large equipment (e.g., bioreactors, tanks, and ancillary systems).
• Conduct cleaning validation studies, execute protocols (IOQ/PQ), and ensure thorough documentation in compliance with regulatory requirements (e.g., FDA, EMA).
• Perform MACO calculations and assessments to determine acceptable residue limits for equipment cleaning.
• Collaborate with cross-functional teams to design and execute cleaning validation strategies and methodologies.
• Develop and execute cleaning validation protocols and reports, ensuring compliance with cGMPs and ALCOA+ principles.
• Provide subject matter expertise in cleaning validation execution and troubleshooting for cleaning processes.
• Lead method validation efforts related to cleaning validation (e.g., swab and rinse sampling).
• Ensure alignment with process and equipment design specifications for cleaning requirements.
• Provide technical training and guidance to operators and validation personnel on cleaning validation principles and techniques.
• Support audits and inspections by providing cleaning validation documentation and expertise.
• May participate in shift work as required to support cleaning validation activities during different phases of production.

Qualifications:

• Bachelor's degree in a relevant scientific or engineering discipline (e.g., Chemical Engineering, Biotechnology, Chemistry) or equivalent experience.
• 5+ years of experience in cleaning validation, with a strong focus on CIP processes and large equipment.
• Proven expertise in MACO calculations, cleaning validation protocol execution, and method validation techniques.
• Familiarity with biopharmaceutical manufacturing processes and regulatory standards (21 CFR Part 11, ICH Q7, etc.).
• Hands-on experience with large-scale equipment, including bio-reactors, tanks, and associated cleaning systems.
• Strong problem-solving skills and ability to troubleshoot cleaning-related issues effectively.
• Excellent technical writing and documentation skills.
• Flexibility to work day and night shifts as operational needs evolve.

Preferred Qualifications:

• Experience in a large-scale biopharmaceutical manufacturing environment.
• MACO- MUST
• KNEAT experience a plus
• Knowledge of automated cleaning systems and CIP equipment design.
• Familiarity with process validation and cross-contamination control strategies.
• Small Parts COP and CIP execution experience

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