Cleaning Validation Engineer
Cleaning Validation Engineer
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Job Description
Job Description:
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 bioreactors. 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.
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.
Requirements:
- Bachelors 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 workday and night shifts as operational needs evolve.
- 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
