Deviation Management Specialist I Position Available In Montgomery, Pennsylvania

Deviation Management Specialist

I 4.0 4.0

out of 5 stars West Point, PA 19486

Job Title:

Deviation Management Specialist Duration:

12 months

Location:

West Point, PA Job Summary:

The Deviation Management Contractor will be responsible for technical support to vaccine manufacturing. This engineer will be a member of the Technical Operations Deviation Management team within the manufacturing division at the West Point site. The primary responsibility of the individual will be investigation initiation and closure associated with manufacturing deviations and development of actions in response to these deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing). 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. This position is a site-based assignment and requires the employee to work at the site M-F. Two days of remote work per week may be available, work permitting, but is not guaranteed. Off-shift or weekend coverage may be required based on business unit needs and specific assignments.

Responsibilities include:

Leads and/or works as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause. Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize, and/or gain efficiencies. Manages timelines to ensure key compliance and customer due dates are met; escalates any potential misses and develops remediation plans when possible. 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. Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

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