Cleaning Validation Engineer

Cleaning Validation Engineer
AMC197
11 month contract
Carlow

I am currently on the look out for a Cleaning Validation Engineer for a Biopharmaceutical manufacturing plant in Carlow. This is the perfect role for someone with Cleaning validation experience looking for their next contract.

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.e.
• 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