Senior Specialist, Engineering

Job Description

The Senior Specialist, Engineering, will be responsible for support of production of live virus vaccines within bulk vaccine production and/or final formulation and filling operations. This engineer will be a member of the Technical Operations Deviation Management team in the Live Virus Vaccine Manufacturing End-to-End at the West Point site.  The primary responsibility of the individual will be leading investigations associated with manufacturing deviations and development of actions in response to these deviations. 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 corresponding IPT operations. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. 

 

Responsibilities include: 

• Leads manufacturing investigations, identifying root cause, assessing impact, and recommending corrective actions. 

• Examines issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause. 

• Assures consistent application of standardized work, engineering, project management 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. 

• Provides document review, coaching and training to team members. 

• Drives continuous improvement of deviation management and associated processes. 

Education Minimum Requirements: 

• B.S. degree in Engineering or Sciences. 

Required Experience and Skills: 

• Minimum four (4) years post-bachelor’s degree experience in GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing (or M.S. degree with 2 years experience). 

• Demonstrated ability to drive results 

• Strong communication, collaboration skills and ability to drive accountability 

• Strong problem-solving skillset 

Preferred Experience and Skills: 

• Vaccine manufacturing 

• Sterile processing 

• Experience authoring investigations 

 

Required Skills:

Adaptability, Corrective Action Management, Customer-Oriented, Deviation Management, Engineering Standards, GMP Compliance, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing, Manufacturing Process Validation, Manufacturing Support, Operations Support, Process Optimization, Project Management, Project Management System, Project Planning, Project Resource Management, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Teamwork, Technical Support, Technical Transfer, Viral Vaccines

Preferred Skills:

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