Cleaning Validation Engineer
AMC197
11-month contract
We seek an experienced Cleaning Validation Engineer for a Biopharmaceutical manufacturing plant in Carlow. This is an ideal role for someone with Cleaning validation experience looking for their next challenge.
Responsibilities:
* Ensure site cleaning practices adhere to external auditing standards and cGMP regulations.
* Act as 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 complex investigations and cleaning improvement projects, clearly communicating progress.
* Support daily cleaning issue investigations, ensuring Corrective and Preventive Actions (CAPAs) are in place.
* Participate in or lead the Cleaning Community of Practice, collaborating across sites within the company's network.
* Work alongside internal and external stakeholders, including Compliance Owners, to facilitate investigations and process enhancements.
Requirements:
* PhD in Chemistry, BE/ME Chemical Engineering, Pharmaceutical Sciences, or related field.
* Minimum 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 improvements.
This challenging role offers opportunities for growth and professional development.