QA Validation Specialists (CTU and SIP)

Europe / Ireland  /  Europe/Ireland  /  Full Time


Our Clients are looking for us to fill some exciting, challenging and rewarding positions. 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 Specialists (CTU and SIP)
Experienced in QA Validation activities
Commissioning, qualification and thermal mapping of  CTUs ( Fridges, freezers, incubators and stability units ) to compliance with cGMP regulations ensuring  the integrity of stored materials.
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 SIP (Steam in Place) and Controlled Temperature Units (CTU's)
Experience in KAYE validator usage
Experience in SIP thermal mapping, TC and BI placement
Experienced in CTU thermal mapping ( Fridges, freezers, incubators and stability units)
Experience in Deviation writing,
Troubleshooting to investigate issues if and when they occur.
An excellent understanding of how manufacturing and steam sanitisation and sterilisation works
Generate/review/Approval of SIP/CTU protocols,
Generate Reports,
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