-
Minimum education - Bachelor's or Master degree in Life Sciences, Pharmacy, Chemistry
-
Biology or related Engineering discipline (Chemical Engineering).
-
Minimum of 3-5 years of professional hands-on and direct cleaning validation experience (CIP;COP; Manual Cleaning) in pharmaceutical / biotech industries
-
Extensive knowledge of various cleaning techniques and technology.
-
Broad knowledge of regulatory compliance and its relation to cleaning of product contact equipment in the biopharmaceutical manufacturing environment
-
Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
-
Excellence in writing, reviewing and executing cleaning verification / validation protocols;
-
design of experiments (DOE); risk assessment and technical reports.
-
Strong project leadership skills.
-
Proven assessment, analytical and problem-solving skills.
-
Working experience in adopting ASTM E2500 standards
-
Current member of ISPE in Cleaning Validation
-
Expertise and experience with the contract development manufacturing and sterile / aseptic
operations
-
General knowledge of process flows and personnel flows in the biopharma manufacturing
environment.
