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, Switzerland, Singapore 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.
We are currently recruiting for a permanent PMT Specialist to join our growing team in Europe.
· Minimum bachelor’s degree in Chemistry, Pharmacy, Chemical, Biotechnology or Biochemical Engineering.
· 10+ years of experience in Downstream bioprocess operations, Pharma Operations, and Demonstrated experience in equipment design in Pharmaceutical/biopharmaceutical industry.
· Experience in an engineering role supporting cGMP operations in a Pharmaceutical/biopharmaceutical manufacturing plant is highly desirable.
· Experience in the design and operation of biopharmaceutical and/or Pharma manufacturing equipment and facilities.
· Experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors.
· Experience in the execution and management of tech transfer of drug products and/or drug substances
· Process and equipment knowledge of biological drug substance manufacturing processes; downstream unit operations expertise highly preferable.
· PMI certification is highly preferred.
· Read &Understand PCS7 Functional Specification and Knowledge/ Experience in Siemens PCS7 is preferable.
· Knowledge/ Experience in DeltaV, is an added advantage.
· Understanding equipment commissioning, various stages of qualification and process activities.
· Thorough knowledge of current Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP).
· Good understanding of design principles and standards within the biopharmaceutical facilities.
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
For more information contact Michael O’Leary on 00353 86 0575973 or on email at firstname.lastname@example.org