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Deviation Specialist
1 month ago
About the Role:
We are seeking a motivated individual with a B.S./M.S. degree in an appropriate engineering or scientific field to join our team.
The ideal candidate will have 0-3 years of experience in a cGMP environment within the pharmaceutical/biotech industry.
This role will involve providing technical support to manufacturing operations, investigating process deviations, and developing corrective/preventative actions.
Responsibilities:
Provide day-to-day technical support to manufacturing operations Resolve and reduce process deviations
Develop and implement corrective/preventative actions
Lead manufacturing and laboratory investigations
Develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release Utilize scientific and engineering principles to investigate process deviations
Troubleshoot and conduct root cause analysis of laboratory test failures and manufacturing atypical events
Design and execute laboratory/pilot scale experiments
Education Qualification:
B.S./M.S. degree in an appropriate engineering or scientific field
Required Skills:
Previous experience in writing investigations for atypical events in a manufacturing environment
Familiarity with Lean Six Sigma Methodologies
Proven analytical and problem-solving capabilities
Ability to work independently and as part of a cross-functional team
Excellent written and verbal communication skills
Investigational Technical Writing Skills
