Deviation Management Specialist - I (Assistant)

Net2Source•West Point, PA

1d•Hybrid

About The Position

Net2Source Inc. is hiring a Deviation Management Specialist - I (Assistant) for a 12-month contract assignment in a hybrid setting at 770 Sumneytown Pike, West Point, Pennsylvania. The role supports manufacturing areas within the client’s Manufacturing Division by providing technical and scientific support on the production floor and helping resolve and reduce process deviations. The specialist leads manufacturing and laboratory investigations, applies scientific and engineering principles to investigate deviations, troubleshoots atypical manufacturing events and laboratory test failures, and develops and implements corrective and preventive actions. The role also involves analyzing complex problems and designing and executing laboratory- or pilot-scale experiments. Success at the end of the assignment means controls across all four workstreams are implemented and documented, SOPs and job aids are approved, training is deployed, and the project record is complete and ready for handoff to the permanent compliance organization. The position is scheduled for 8:00 a.m. to 5:00 p.m., Monday through Friday, for 40 hours per week. The stated pay rate is $41.78 per hour on W-2.

Requirements

B.S. or M.S. degree in an appropriate engineering or scientific field.
One to three years of post-bachelor’s experience in a cGMP environment, such as production, development, process engineering, technical services, or a related field in the pharmaceutical or biotechnology industry; academic or internship experience is accepted.
Previous experience writing investigations that include root cause analysis and development of corrective and preventive actions for atypical events in a manufacturing environment.
Familiarity with Lean Six Sigma methodologies and demonstrated analytical and problem-solving capabilities.
Ability to work independently and as part of a cross-functional team.
Excellent technical and scientific writing and verbal communication skills.

Responsibilities

Resolve and reduce process deviations.
Develop and implement corrective and preventive actions.
Lead manufacturing and laboratory investigations.
Provide technical and scientific support on the production floor for manufacturing areas within the client’s Manufacturing Division.
Develop working relationships with counterparts supporting aseptic manufacturing, testing, planning, and release.
Apply scientific and engineering principles to investigate process deviations.
Troubleshoot laboratory test failures and atypical manufacturing events, perform root cause analysis, and develop corrective and preventive actions.
Analyze complex problems through critical analytical thinking and design and execute laboratory- or pilot-scale experiments.
Help ensure controls in all four workstreams are implemented and documented, SOPs and job aids are approved, training is deployed, and the project record is ready for handoff.