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Regulatory Validation Specialist

1 week ago

Limerick, Limerick, Ireland TN Ireland Full time
Job Description

A highly skilled Validation Technical Writer is required by TN Ireland to work with our biotech client on a 12-month contracting position.

Role Responsibilities:

  1. Report Generation: Produce high-quality summary reports that meet regulatory requirements.
  2. Document Development: Write, review and approve deviation/GMP documents in accordance with industry standards.
  3. Cleaning/ SIP Validation Management: Maintain and update cleaning/SIP validation plans to ensure compliance.
  4. Scheduling: Coordinate cleaning/SIP activities with manufacturing teams.

Requirements:

  1. A relevant third-level degree (Bachelor's or Master's) in a field such as life sciences or engineering.
  2. At least two years of experience in a related role within the pharmaceutical or biotechnology industry.
  3. Proven expertise as a technical writer, with experience in developing documentation for complex validation processes.
  4. Familiarity with deviation and investigation writing, as well as data review and analysis.
  5. Knowledge of validation principles, particularly SIP/CIP validation, and experience in generating results reports.
  6. A deep understanding of manufacturing processes and equipment used in SIP/CIP validation.