Deviation Management Specialist

Job Title: Deviation Management Specialist

Location: West Point, PA 19486

50% onsite - 3 days office

Duration: 12 Months Contract

Qualifications

• B.S./M.S. degree in appropriate engineering/scientific field
• Minimum of 0-3 years post-Bachelors 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

Responsibilities

• Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations
• Responsible for providing scientific support for manufacturing areas within client's Manufacturing Division (MMD)
• Develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release; 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
• Off-shift work may be required