Title: Deviation Management Specialist - I

Location: West Point, PA 19486

Duration: 12 Months

Pay Rate: $41.00/hr

Qualifications:

Education Minimum Requirements:

• B.S. degree in Engineering or Sciences.

Required Experience and Skills:

• Minimum one (1) year post-bachelor’s degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with <1 year experience).

• Demonstrated ability to drive results to hit assigned due dates.

• Strong communication, collaboration skills and ability to drive accountability.

• Strong problem-solving skillset

Preferred Experience and Skills:

• Vaccine manufacturing

• Sterile processing

• Experience authoring

Responsibilities:

The Deviation Management Contractor will be responsible for deviation management activities in support of vaccine production at the West Point site.

This engineer will be a member of the Technical Operations Deviation Management team within the ROTA End-to-End (E2E) technical operations unit.

The primary responsibility of the individual will be investigation initiation and closure associated with vaccine technology/production in support of the operations taking place in the ROTA E2E.

Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/equipment actions, and other related duties.

This position will require development of technical expertise of process and product knowledge.

Responsibilities:

• Leads and/or works as a team member on manufacturing investigations and/or process improvement projects.

• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to identify root cause and propose effective corrective and preventative actions (CAPAs).

• Assures consistent application of standardized work, engineering, and process tools.

• Provides technical support to manufacturing shop floor for problems and issues.

• Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

• Writes technical documents to support closure of deviations using the SAP system.

• Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.