Position: Assistant Deviation Management Specialist
Location: West Point, PA
Duration: 12 Months

Job Description:

• 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.
• This individual will be responsible for providing scientific support for manufacturing areas within the Manufacturing Division.
• 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.
• Responsibilities also include troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, as well as the development of corrective/preventative actions.
• 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.

Qualifications:

• B.S./M.S. degree in an appropriate engineering/scientific field.
• Minimum of 0-3 years post-Bachelor's degree experience in a cGMP environment (e.g., Production, Development, Process Engineering, Technical Services, or related field) in the pharmaceutical/biotech industry.
• Previous experience in writing investigations for atypical events in a manufacturing environment.
• Familiarity with Lean Six Sigma methodologies and proven analytical/problem-solving capabilities.
• Demonstrated ability to work both independently and as part of a cross-functional team.
• Excellent written and verbal communication skills.

Must-haves:

• Investigational Technical Writing Skills.
• Highly developed communication, leadership, and teamwork skills.
• Ability to manage projects/work to schedule/deadlines.
• Coherent communication skills (no proofreading), technical manufacturing experience (specifically supporting vaccines).
• Ability to meet a 5-day turnaround time on report writing