Position: Assistant Deviation Management Specialist
Location: West Point, PA
Duration: 12 months
Note: Position is typically Hybrid- 3 days on-site/2 days remote.
Will be more on-site initially until trained
Top Skill sets: Technical Writing/investigation experience.
Demonstrated capability of meeting goals/timelines/organizational skills (Project Manager skill sets)
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 investigations
This individual will be responsible for providing scientific support for manufacturing areas within Client'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
Off-shift work may be required
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 of meeting goals/timelines/organizational skills
Excellent written and verbal communication skills
Demonstrated ability to work both independently and as a part of a cross-functional team
Preferable skills-Environmental monitoring experience, Formulation and filling experience, Line manufacturing experience (project engineer, maintenance and facility engineer, Experience in Bulk/Drug substance Manufacturing).
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