QA Validation - SIP

Europe / Ireland  /  Europe/Ireland  /  Full Time


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 - SIP
Experienced in QA Validation activities  
Review & approval of SIP thermal mapping and Performance Qualification validation protocols
Extensive experience on writing and approving Deviations
Technical writing experience for generation of protocols and reports.
Essential Duties and Responsibilities include, but are not limited to, the following:
Experience in Validation specifically Steam in Place
Experience in KAYE validator usage
Experience in review and approval of KAYE validator report and study runs,
Experience in SIP thermal mapping, TC and BI placement
Experienced Technical writer,
Experience in Deviation writing,
Troubleshooting to investigate issues if and when they occur.
An excellent understanding of how manufacturing and steam sanitization and sterilization works
Generate/review/Approval of SIP protocols,
Generate Reports,
Schedule of SIP activities with Manufacturing
Liaise with numerous departments
 
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

APPLY FOR THIS JOBALL OPEN POSITIONS

CAI BENEFITS

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year
  • Medical / Dental / Vision
  • Professional Development
    (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave
  • No Layoffs in Company History