Cleaning Validation Consultant

Profile

Role:Cleaning validation
Location: Milford, MA
Contract Duration: 6 months
Required Skills:
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.
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