Deviation Management Specialist - I (Assistant)
American Cybersystems, Inc.

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 Merck'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

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 within Merck'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). In addition to Deviation Management, will be authoring updates to Batch Records and Standard Operating Procedures.