Technical Writer, Validation (12M, Limerick)

Technical Writer required by CareerWise Recruitment for our multinational biotechnology client in Limerick, initial 12 month contract on offer. The Technical Writer needs to have experience in writing protocols and deviations for equipment qualification and general validation.

Role of this position

• Experience in Deviation and investigaton writing
• Experience in Validation specifically CIP/SIP and continuing validation & 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
• Follow all EHS/Safety SOP/Policies

JOB REQUIREMENTS

• Experenced 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

Please call James Farrar today for further information on 0872489961 or email: jfarrar@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.