Cleaning Validation Engineer
AMC9772
12 month contract
Cork - Hybrid

I am currently on the look out for a Cleaning Validation Engineer for a Biopharmaceutical manufacturing plant in Cork. This is the perfect role for someone with API Cleaning validation experience looking for their next contract. On site role with some work from home availability.

Responsibilities:

• Ensure that site cleaning practices adhere to external auditing standards.
• Act as the Subject Matter Expert (SME) for cleaning compliance activities on-site.
• Coordinate with cross-functional teams to align local Standard Operating Procedures (SOPs) making updates as necessary.
• Monitor and analyze cleaning deviations, creating annual action plans to enhance overall performance.
• Lead cleaning improvement projects, clearly communicating progress on these initiatives.
• Support investigations related to daily cleaning issues, ensuring that Corrective and Preventive Actions (CAPA) are in place to prevent recurrence.
• Participate in or lead the Cleaning Community of Practice, collaborating across four API sites within the company's network.
• Work alongside internal and external stakeholders, including Compliance Owners, to facilitate investigations, implement improvements, manage change controls, and develop CAPAs.
• Lead complex investigations with cross-functional teams by applying analytical and problem-solving skills to identify root causes, assess impacts, and execute process enhancements.

• PhD in Chemistry, BE/ME Chemical Engineering, Pharmaceutical Sciences, or related field.
• Previous API cleaning experience in deviation management and/or API cleaning compliance.
• Minimum of 2 years of experience in a similar role within the pharmaceutical industry or equivalent.
• 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 initiative