Title: Deviation Management Specialist - I (Assistant)
Qualifications:
- 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 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.
- Real-time troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, with the goal of fully understanding root cause and product impact and development of corrective/preventative actions is required
- 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
Quals
Education Requirement: B.S./M.S. in Mechanical or Chemical Engineering degree or other science degree.
Preferred Experience and Skills:
- 0-3+ years of relevant work experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry.
- Support of vaccine operations or technical services support.
- Support of deviation investigations and/or project work.
- Previous experience in writing investigations for atypical events in a manufacturing environment.
- Experience with troubleshooting biotech equipment, barrier technology, and closed system processing.
- Experience with, MEDS, SAP
- Ability to read Piping and Instrumentation Diagrams
- Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities
- Demonstrated ability to work both independently and as a part of a cross-functional team
- Excellent written and verbal communication skills
