An MSAT Engineer (Cleaning Validation Specialist) is required on an initial 12 M basis by CareerWise Recruitment for our Cork-based multinational Biopharmaceutical Company.
THE ROLE:
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 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.
Participate or Lead the Cleaning Community of Practice, working across 4 API sites in 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.
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.
Please call Aisling O’Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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