A Cleaning Validation Specialist in the pharmaceutical industry is responsible for ensuring that cleaning processes within manufacturing facilities meet regulatory standards and are effective in removing residues of drugs, cleaning agents, or other contaminants from equipment, surfaces, and manufacturing areas.
What you will do:
- Execute QA Validation activities, focusing on Steam in Place (SIP) processes.
- Review and approve SIP thermal mapping and Performance Qualification validation protocols.
- Write and approve deviations as necessary.
- Produce technical documentation, including the generation of protocols and reports.
- Oversee the placement of temperature sensors (TC) and biological indicators (BI).
- Troubleshoot and investigate issues related to SIP processes.
- Coordinate and schedule SIP activities with Manufacturing departments.
- Collaborate and communicate effectively with various departments.
What you need:
- Proficiency in Validation procedures, particularly in Steam in Place processes.
- Familiarity with KAYE validator usage and the review and approval of KAYE validator reports and study runs.
- Experience in SIP thermal mapping, TC, and BI placement.
- Strong technical writing skills, with a proven track record in generating protocols and reports.
- Ability to write and manage deviations effectively.
- Comprehensive understanding of manufacturing processes, particularly in steam sanitization and sterilization.
- Demonstrated capability to generate, review, and approve SIP protocols and reports.
- Proven ability to coordinate and schedule SIP activities with Manufacturing departments.
- Excellent interpersonal skills with the ability to liaise effectively with numerous departments.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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