Deviation Management Specialist

Deviation Management

Pay Rate: $41.50

Location:

770 Sumneytown Pike, West Point, PA

• 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)

• 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

Brief team meeting. Assign investigations. Work on investigations (interviewing others, write-up at desk, SAP data mining). 80% Desk/20% meetings Position is typically Hybrid- 3 days on-site/2 days remote after fully trained. Will be more on-site initially until trained Top Skillsets
- Technical Writing/investigation experience. Demonstrated capability of meeting goals/timelines/organizational skills (Project Manager skillsets) kindly get back with your latest resume and answers to following questions

Q1-How many years of exp in ( e.g. Production, Development, Process Engineering, Technical Services or related field) pharmaceutical/ biotech industry

Q2-How many years of exp in reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations

Q3-How many years of exp in Technical writing - this exp is very much preferred

Q4- how far you stay from 770 Sumneytown Pike, West Point, PA and how will you commute daily