Job Summary
A Validation Technical Writer is required to work with our biotech client on a 12-month contracting position. The successful candidate will be responsible for generating summary reports, writing and approving deviations/GMP documents, maintaining and updating cleaning/SIP validation plans, and scheduling cleaning/SIP activities with manufacturing.
Key Responsibilities
* Generate summary reports detailing validation activities.
* Write and approve deviations/GMP documents in accordance with regulatory requirements.
* Maintain and update cleaning/SIP validation plans to ensure compliance.
* Schedule cleaning/SIP activities with manufacturing to minimize downtime.
Requirements
* Relevant third-level degree (e.g., engineering, science, or technology).
* Minimum two years of relevant industry experience.
* Experienced technical writer with a strong understanding of validation principles.
* Experience in deviation and investigation writing and data review.
* Experience in validation specifically SIP/CIP validation.
* Experience in reviewing and reporting SIP/cleaning validation results beneficial.
* Understanding of how manufacturing and SIP/CIP validation equipment works.