About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, headquartered in Pomona, California, USA, with Global operations in
Ireland, India, Singapore, Australia and the US, serving 350 clients in more
than 23 countries worldwide. We provide cloud-based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals contract
manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’PSC Biotech disrupts the conventional consultancy model
by aligning our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like-minded professionals
operating in the Pharma/ Biotech Industry. We offer a permanent contract of
employment giving exposure of working in Top Pharmaceutical client sites in a
diverse-cultural work setting. Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in-house training mentorship through constant guidance to facilitate career
progression. We believe in creating high performing teams that can exceed our
client’s expectations with regards to quality of all scalable and business unit
deliverables, staying under budget and ensuring timelines for our deliverables
are being met.Technical Writer - Cleaning Validation SIPAn 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.RequirementsResponsibilities:Experienced Technical writerExperience in Deviation and investigation writing,Experience in Validation specifically CIP/SIP and
continuing validationExperience in assessment of CIP/SIP issues during study
runs and closeout of deviationsExperience in KAYE validator reporting review beneficialCapable of managing a large program, so project
management skills would be necessary,An understanding of how manufacturing, CIP and SIP
Validation equipment worksGenerate/review/Approval of SIP protocolsGeneration of Summary Reports and strong quality
background essentialExperience in continuing validation and generation of
assessments for continuingAssessment of impact of issues/ deviations which arise
through the assessment generation.Maintain and update Cleaning/ SIP Validation PlanSchedule of Cleaning/ SIP activities with Manufacturing Qualifications and Experience:Bachelors Degree in Science or EngineeringExperienced in QA Validation activities –Execution, review & approval of SIP/ CIP and
continuing validation protocols and closureExtensive experience on writing and approving DeviationsTechnical writing experience has written a number of
white papers and site reports.Technical writing experience for continuing assessments Skills:Cleaning Validation SIP cip Technical Writing