Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2020 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals. CAI offers you control of your career, your professional development, your growth and path to success.
Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organisation headquartered in the United States with offices in Ireland, Netherlands, Italy, Puerto Rico, Singapore, China and Malaysia. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. We work in the areas of automation, commissioning and qualification, validation, maintenance and reliability, building commissioning, consulting and information management systems.
QA Validation - Technical Writer
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
Essential Duties and Responsibilities include, but are not limited to, the following:
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.
Ability to work on own initiative
Maintain and update Cleaning/ SIP Validation Plan
Schedule of Cleaning/ SIP activities with Manufacturing
Liaise with numerous departments
Shows focus & a consistence approach to the role and tasks.
Excellent people skills
Ensure Training is maintained and current.
Follow all EHS/Safety SOP/Policies
Actively look for Continuous improvements
In return for your skills and knowledge, CAI offers a wide range of benefits including:
Health insurance, company paid critical illness insurance, Life Insurance, PRSA contribution and more
Annual profit sharing
Paid time off
Continuing Professional Development and Education (internal and external)
Opportunity to work abroad if desired