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Client:
CareerWise Recruitment
Location:
Cork, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
59c79c92e9e9
Job Views:
114
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
An MSAT Engineer (Cleaning Validation Specialist) is required on an initial 12 M basis by CareerWise Recruitment for our Cork-based multinational Biopharmaceutical Company.
Role of this position:
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 requirements. Update procedures as required. Monitor and trend cleaning deviations and develop yearly action plans to improve performance. Lead the cleaning improvement projects on site, clearly displaying progress on projects. Support the investigation leads on day-to-day cleaning issues ensuring CAPA prevents 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.
Job 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.
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