Job Description
Cleaning Validation Specialist
- A 12 month contract position that requires ensuring site cleaning practices are in line with external auditing requirements.
- Serve as the Subject Matter Expert (SME) for cleaning compliance activities on site, leading cross-functional teams and updating procedures as required.
- Monitor and trend cleaning deviations, develop yearly action plans to improve performance, and lead cleaning improvement projects on site, clearly displaying progress.
- Participate in the Janssen Cleaning Community of Practice, working across 4 API sites in the Janssen API network, and collaborate with internal and external stakeholders to support investigations and improvements.
- Lead complex investigations with cross-functional teams, applying analytical and problem-solving skills to determine root causes, assess impacts, and implement process improvements.
Requirements:
- 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.
About the Role:
This role is a critical part of the cleaning validation process, ensuring that site cleaning practices meet external auditing requirements. The ideal candidate will have a strong understanding of cGMP regulations and experience in supporting investigations and regulatory audits.
About the Company:
Janssen is a leading pharmaceutical company that is committed to improving the health and well-being of people around the world. We are a global community of professionals who share a passion for innovation and a commitment to excellence.