Job Description

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