Deviation Management Specialist - I (Assistant)

Net2Source•West Point, PA

1d•Hybrid

About The Position

The Deviation Management Specialist provides technical and scientific support on the production floor for manufacturing areas within the client’s Manufacturing Division. The role focuses on resolving and reducing process deviations, leading manufacturing and laboratory investigations, and developing and implementing corrective and preventive actions (CAPAs). The specialist works with counterparts supporting aseptic manufacturing, testing, planning, and release, applying scientific and engineering principles to investigate process deviations and atypical events. The position also involves troubleshooting laboratory test failures and manufacturing events, analyzing complex problems, and designing and executing laboratory- or pilot-scale experiments. The assignment is a 12-month contract, based in West Point, Pennsylvania, with a hybrid work arrangement and a Monday-to-Friday schedule from 8:00 a.m. to 5:00 p.m. At the end of the assignment, controls across four workstreams are expected to be implemented and documented, SOPs and job aids approved, training deployed, and the project record ready for handoff to the permanent compliance organization.

Requirements

B.S. or M.S. degree in an appropriate engineering or scientific field.
1–3 years of post-bachelor’s experience in a cGMP environment, such as production, development, process engineering, or technical services, in the pharmaceutical or biotechnology industry; academic or internship experience is accepted.
Previous experience writing investigations that include root cause analysis and developing 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/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.
Build working relationships with counterparts supporting aseptic manufacturing, testing, planning, and release.
Use scientific and engineering principles to investigate process deviations.
Troubleshoot laboratory test failures and manufacturing atypical events, determine root causes, and develop corrective and preventive actions.
Analyze complex problems using critical analytical thinking and design and execute laboratory- or pilot-scale experiments.