Cleaning Validation SME

Company: Fusion Life Sciences Technologies LLC
Location: Holly Springs
Posted on: June 4, 2025

Job Description:

12 months

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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

Keywords: Fusion Life Sciences Technologies LLC, Rocky Mount , Cleaning Validation SME, Other , Holly Springs, North Carolina