Cleaning Validation Engineer
AMC9772
12 month contract
Cork - Hybrid
I am currently on the lookout 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.
Requirements:
* 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 initiatives.
If you are interested in this or similar roles, apply today and Angela will be in touch if you are a good fit.
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