Assistant Deviation Management Specialist - ADMS0102#AT01

Title: Deviation Management Specialist 

Location: West Point, PA

Duration: 12 Months

Schedule: Onsite M-F, with potential for up to 2 remote workdays per week (not guaranteed). Off-shift or weekend coverage may be required based on business needs.

Overview:

The Deviation Management Specialist will support vaccine production by leading or assisting in deviation management activities. This includes investigating, resolving, and documenting deviations to ensure smooth operations within the ROTA End-to-End (E2E) Technical Operations unit. The role involves technical expertise in process and product knowledge, as well as cross-functional collaboration to address equipment, process, and operational challenges.

Responsibilities:

• Lead or collaborate on manufacturing investigations and process improvement projects.
• Analyze issues from multiple perspectives (safety, compliance, automation, equipment, process, and people) to identify root causes and propose effective corrective and preventative actions (CAPAs).
• Ensure consistent application of standardized work, engineering, and process tools.
• Provide technical support for manufacturing operations and equipment troubleshooting.
• Design and conduct experimental protocols using lab facilities or production equipment at full scale.
• Write and close technical documents and deviations using the SAP system.
• Author and update technical and manufacturing documents for investigations, process design/definition, engineering studies, process demonstrations, change control, and validation.

Qualifications:

Education:

• Minimum: B.S. degree in Engineering or Sciences.

Required Experience and Skills:

• At least 1 year of post-bachelor's degree experience in GMP manufacturing or technical support of GMP operations. (M.S. degree with less than 1 year of experience is acceptable.)
• Proven ability to meet deadlines and deliver results.
• Strong communication and collaboration skills, with a focus on driving accountability.
• Demonstrated problem-solving capabilities.

Preferred Experience and Skills:

• Experience in vaccine manufacturing or sterile processing.
• Familiarity with authoring technical documents.

Additional Notes:

This site-based role is critical to the success of vaccine production operations and requires a proactive, detail-oriented individual with strong technical and problem-solving skills.