Technical Writer Cleaning Validation Specialist – SIP

An experienced Technical Writer is required to become a key member of

the Cleaning Validation team within a renowned Limerick based Biotech multinational. This is an excellent opportunity to develop your career while working in a dynamic state of the art facility.

Responsibilities:

• Experienced Technical writer,
• Experience in Deviation and investigation writing,
• Experience in Validation specifically CIP/SIP and continuing validation
• Experience in assessment of CIP/SIP issues during study runs and closeout of deviations
• Experience in KAYE validator reporting review beneficial
• Capable of managing a large program, so project management skills would be necessary,
• An understanding of how manufacturing, CIP and SIP Validation equipment works
• Generate/review/Approval of SIP protocols
• Generation of Summary Reports and strong quality background essential
• Experience in continuing validation and generation of assessments for continuing
• Assessment of impact of issues/ deviations which arise through the assessment generation.
• Maintain and update Cleaning/ SIP Validation Plan
• Schedule of Cleaning/ SIP activities with Manufacturing

Qualifications and Experience

• Bachelors Degree in Science or Engineering
• Experienced in QA Validation activities –
• Execution, review & approval of SIP/ CIP and continuing validation protocols and closure
• Extensive experience on writing and approving Deviations
• Technical writing experience has written a number of white papers and site reports.
• Technical writing experience for continuing assessments