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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Cleaning Validation Engineer


Reference:AMC9772 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Specialist

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.

Requirements
  • 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


If you are interested in this or similar roles apply today and Angela will be in touch if you are good fit