Cleaning Validation Specialist

Europe / Ireland  /  Commissioning & Qualification  /  Full Time


Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2021 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.
 
Cleaning Validation Specialist (Initial/ Continuing)
 
Essential Duties and Responsibilities include, but are not limited to, the following:
 
·       Taking Clean hold rinse and swab samples on process equipment and small part
·       Working closely with manufacturing to ensure the CIP/SIP and holds are achieved and samples are taken.
·       Working with engineering to determine flow paths for rinse samples and surface area calculations
·       Shows focus & a consistence approach to the role and tasks.
·       Experience in aseptic technique
·       Experience in Gowning
·       Generating and Executing Validation Protocols.
·       Actively look for Continuous improvements
·       Experience in Validation specifically cleaning/ clean validation
·       Experience in assessment of cleaning issues during study runs,
·       Experienced Technical writer,
·       Experience in Deviation and investigation/Change control writing,
·       An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works
·       Generate/review/Approval of CV protocols,
·       Generate Reports
·       Maintain and update project Cleaning Validation Plans as required
·       Schedule of clean hold activities with Manufacturing
·       Follow all Safety SOP/Policies
·       Actively look for Continuous improvements
·       An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works and load configuration for small parts loads
·       Experience in continuing validation and generation of assessments for continuing
 
Education and Experience:
 
·       Requires a BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 3+ years of related experience within the field; may consider substituting relevant experience for education.
 
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

(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • 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 (In accordance with each countries’ applicable regulations)
  • No Layoffs in Company History
  • Other Benefits Depending on Country