Social network you want to login/join with:
PE Global is currently recruiting for a MSAT Cleaning Validation Engineer on behalf of a leading pharmaceutical company based in Cork. This is an initial 12-month contract role.
Responsibilities:
Cleaning Compliance:
* 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.
Investigations and Innovation:
* 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.
Education and Experience:
* 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.
#J-18808-Ljbffr