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 work arrangement at 770 Sumneytown Pike, West Point, PA. The role supports manufacturing areas within the client’s Manufacturing Division by providing technical and scientific support on the production floor. It focuses on resolving and reducing process deviations, leading manufacturing and laboratory investigations, and developing and implementing corrective and preventive actions (CAPAs).

The specialist will work with counterparts in aseptic manufacturing, testing, planning, and release, applying scientific and engineering principles to investigate deviations. The work includes troubleshooting laboratory test failures and manufacturing atypical events, conducting root cause analysis, and using critical analytical thinking to analyze complex problems and design and execute 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.

Requirements

• Bachelor’s or master’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, technical services, or a related field, in the pharmaceutical or biotech 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.
• 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 manufacturing atypical events and conduct root cause analysis.
• Analyze complex problems using critical thinking and design and execute laboratory- or pilot-scale experiments.

What This Job Offers

• Career Level: Entry Level