• Primary responsibilities include resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations
• This individual will be responsible for providing Deviation Management support for bulk vaccine manufacturing area.
• This Individual is required to utilize sound scientific and engineering principles to investigate process deviations
• Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required
• Analysis of complex problems through critical analytical thinking is required
• Off-shift work may be required based on specific assignment.
Required Qualifications and Experience:
• B.S./M.S. degree in appropriate engineering/scientific field
• Minimum of 4-8 years post-bachelor’s degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry
• Previous experience in writing investigations for atypical events in a manufacturing environment
• Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities
• Demonstrated ability to work both independently and as a part of a cross-functional team
• Excellent written and verbal communication skills