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Job Description
Seeking a Cleaning Validation Engineer with API cleaning experience to ensure site cleaning practices adhere to external auditing standards in a Biopharmaceutical manufacturing plant.
This role involves ensuring cleaning compliance, coordinating with cross-functional teams, and leading cleaning improvement projects.
Cleaning Validation Engineer
Join our team as a Cleaning Validation Engineer and take on a challenging role that requires expertise in API cleaning validation and compliance.
- Ensure site cleaning practices adhere to external auditing standards
- Act as Subject Matter Expert (SME) for cleaning compliance activities
- Coordinate with cross-functional teams to align local Standard Operating Procedures (SOPs)
- Monitor and analyze cleaning deviations, creating annual action plans
- Lead cleaning improvement projects, clearly communicating progress
- Support investigations related to daily cleaning issues
- Participate in or lead the Cleaning Community of Practice
- Work alongside internal and external stakeholders to facilitate investigations and implement improvements
Requirements:
- Ph D in Chemistry, BE/ME Chemical Engineering, Pharmaceutical Sciences, or related field
- Previous API cleaning experience in deviation management and/or API cleaning compliance
- Minimum of 2 years of experience in a similar role within the pharmaceutical industry or equivalent
- Strong understanding of c GMP regulations and experience in supporting investigations and regulatory audits
- Excellent communication and collaboration skills