Cleaning Process Specialist

1 week ago

Carlow, Ireland beBeeValidation Full time €60,000 - €90,000

Job Summary:

This role is responsible for ensuring the effectiveness of cleaning validation processes and strategies in a highly regulated environment.

The ideal candidate will have experience as a validation specialist in a pharmaceutical or similar setting, with a strong background in chemical engineering, biochemistry, microbiology, chemistry, or a related field.

Main Responsibilities:

  • Develop and execute cleaning cycle development and qualification protocols for equipment.
  • Write and implement validation strategies, collaborate with vendors, write protocols independently, submit samples, analyze test results, and prepare technical reports.
  • Conduct business activities such as equipment periodic reviews, cleaning periodic reviews, CAPAs, deviations, change control, risk assessments, and commissioning support.
  • Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
  • Prepare and present technical reports, perform statistical analysis of data.
  • Maintain compliance with the latest regulatory guidelines.
  • Represent the IPT on cross-functional project teams.
  • Provide technical input and support during regulatory inspections.
  • Ensure highest standards for Quality, Compliance, and Safety by participating in and complying with our Manufacturing Division Quality Management System requirements.

Requirements:

  • Experience as a validation specialist in a pharmaceutical or highly regulated environment and a Bachelor of Science degree or equivalent in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field.
  • Proven experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
  • Familiarity with GxP systems associated with this role, including GLIMS and eVAL, electronic batch records.

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