Deviation Management Specialist

Deviation Management Engineer

Location: 770 Sumneytown Pike, West Point PA Rate: $41/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

Must have Skills:

Vaccine manufacturing

Sterile processing

Experience authoring

Responsibilities:

The Deviation Management individual 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. This is 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 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.

If interested, kindly share your updated resume with Answers.

a) How many years of experience in (e.g. Production, Development, Process Engineering, Technical Services or related field) pharmaceutical/biotech industry

b) How many years of experience in reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations

c) How many years of experience in Technical writing - this experience is very much preferred