Title: Deviation Management Specialist – II
Location: West Point, PA
Start date: ASAP
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 investigations
- This individual will be responsible for providing scientific support for manufacturing areas.
- 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
Requirements:
- B.S./M.S. Degree in appropriate engineering/scientific field
- Minimum of 3-5 years post-Bachelor's 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).
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Company:System OneLocation:Pennsylvania - United StatesJob Types:ContractPost Date:October 27, 2021Valid Through:November 26, 2021