Job Description
An MSAT Engineer (Cleaning Validation Specialist) is required on an initial 12-month basis for a Cork-based multinational Biopharmaceutical Company.
Role of this Position
Ensure site cleaning practices align with external auditing requirements. Serve as Subject Matter Expert (SME) for cleaning compliance activities. Mobilize cross-functional teams to ensure local SOPs meet Global and external agency requirements. Update procedures as needed. Monitor and trend cleaning deviations, developing yearly action plans to improve performance.
Lead cleaning improvement projects, displaying progress clearly. Support investigation leads on day-to-day cleaning issues, ensuring CAPA prevents recurring items. Participate in or lead the Cleaning Community of Practice across 4 API sites within the API network. 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.
JOB REQUIREMENTS
A 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 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.