Job Description:
PE Global is seeking a highly skilled MSAT Cleaning Validation Engineer for a leading pharmaceutical company based in Cork. This is an initial 12-month contract role.
Key Responsibilities
* Ensure site cleaning practices comply with external auditing requirements and global standards.
* Serve as the Subject Matter Expert (SME) for cleaning compliance activities on site.
* Mobilize cross-functional teams to update local SOPs in line with global and external agency requirements.
* Monitor and trend cleaning deviations, developing yearly action plans to improve performance.
* Lead cleaning improvement projects on site, clearly displaying progress.
* Support investigation leads on day-to-day cleaning issues, ensuring CAPA prevent recurring items.
* Participate or lead the Cleaning Community of Practice across 4 API sites in the API network.
Investigations and Innovation
* Collaborate with internal and external stakeholders 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 and implement process improvements.
Requirements
* PhD in Chemistry, BE/ME Chemical Engineering, Pharmaceutical Sciences, or related field.
* Minimum 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.
Application Instructions