Cleaning Validation Specialist

• Responsible to ensure site cleaning practices are in line with external auditing requirements.
• Serve as the Subject Matter Expert (SME) for cleaning compliance activities on site.
• Mobilize cross-functional teams to ensure local SOPs are in line with Janssen Global and external agency requirement. Update procedure as required.
• Monitor and trend cleaning deviations and develop yearly action plans to improvement performance.
• Led the cleaning improvement projects on site, clearly displaying progress on projects in projects
• Support the investigation leads on day to day cleaning issue ensuring CAPA prevent recurring items.
• Collaborate with internal and external stakeholders, including Compliance Owners to support investigations /improvements, change controls, and CAPA development.
• Lead complex investigations with cross-functional teams, applying analytical and problem-solving skills to determine root causes, assess impacts, and implement process improvements.

• PhD in Chemistry, BE/ME Chemical Engineering, Pharmaceutical Sciences, or related field.
• Minimum of 2 years of experience in a similar role within the pharmaceutical industry or equivalent.
• Previous API cleaning experience in deviation management and/or API cleaning compliance.
• Strong understanding of cGMP regulations and experience in supporting investigations and regulatory audits.
• Excellent communication and collaboration skills, with the ability to lead cross-functional teams and drive process improvement initiatives.
• Demonstrated leadership abilities, including experience in project management and team coordination.

Cpl Group