Chantay McNeil

Process Engineer Iii @Novo Nordisk

Oversee equipment validation, verification, equipment release and cleaning monitoring programs • Ensure development of & adherence to the CIP (Clean-In-Place), COP (Clean-out-of Place), and manual cleaning strategy for the production facili validation plans, SOPs. • Execute validation Performance Qty. • Author and implement cleaning qualifications in support of manufacturing API. • Training of Manufacturing Associates in support of cleaning validation (i.e. sampling, trending, trouble shooting) • Consult on equipment validation impact for project planning • SME (Subject Matter Expert) of the drug substance production process. • Identifying and establishing of the worst case cleaning paths for each equipment type. • Communication across functional areas • Develop cleaning validation methodologies and strategy • Conduct technical review and revision of client Standard Operating Procedures for Laboratory Information Management Systems (LIMS). • Collaborate with Engineering teams on cGMP approaches to optimize designs for efficient validation and to ensure cGMP compliance. • Provide regulatory guidance and approach to medical device manufacturers in support of process changes, passivation, cleaning and remediation activities.