JOB DESCRIPTION:

Most Important: The candidate needs to have current industry Cleaning Validation knowledge. Past work in CDMO and/or drug product facility is a plus. Kneat experience is really needed. The candidate needs to be able to work across functions and departments. Strong Biologics experience preferred - DPFG (Drug Product Finish Goods Team) vial fill finish most important must have experience. Looking for strong references to be considered and hired.
Shift: Primarily Day Shift; potential for Night Shift work in the future
Job Summary:
We are seeking an experienced Cleaning Validation Workers to work on 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.

Please refer the Job description for details