Sr. Specialist, Engineering

Job Description

The Sr. 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 Services 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 investigation initiation and closure 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 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) to best understand and resolve the root cause and implement actionable/effective 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.
• Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
• Supports Internal/External Inspections as an SME
• Provide project management support for various improvement and compliance projects
• Present at and participate in key Tier meetings and Strategic Planning meetings

Minimum Education Requirements and Experience:

• Bachelor of Science (B.S.) degree in Engineering or Sciences with four (4) years’ experience in a GMP manufacturing and/or technical support in GMP manufacturing operations; OR
• Master of Science (M.S.) degree in Engineering or Sciences with three (3) years’ experience in a GMP manufacturing and/or technical support in GMP manufacturing operations

Required Experience and Skills:

• Demonstrated ability to drive results
• Strong communication, collaboration skills and ability to drive accountability
• Strong problem-solving skillset
• Deviation Management Experience (Quality Approver, QN Author, Technical Approver)
• Regulatory Inspection Experience
• Experience with SOP Management

Preferred Experience and Skills:

• Vaccine manufacturing
• Sterile processing and Aseptic Gowning
• Quality Risk Assessment experience (in any capacity)
• Live Virus Vaccine Experience (Drug Substance or Drug Product)
• Environmental Monitoring and Process Simulation Experience

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