Deviation Management Specialist - I (Assistant)

Qualifications

• B.S./M.S. degree in appropriate engineering/scientific field
• Minimum of 1-3 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; Academic/internship experience accepted
• Previous experience in writing investigations with root cause analysis and corrective and preventative action (CAPA) development 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 technical/scientific writing and verbal communication skills

• 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 on production floor technical/scientific support for manufacturing areas within ***’s Manufacturing Division (MMD)
• This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and 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 and the design/execution of laboratory/pilot scale experiments is required