Specialist, Engineering

Job Description

Specialist, Engineering 

Our company is seeking a highly motivated Specialist, Engineering to join our Technical Operations Deviation Management team within our manufacturing division at the West Point site. This role is crucial in providing engineering technical support for live virus bulk vaccine production. If you are passionate about driving innovation and ensuring the highest standards in vaccine manufacturing, we invite you to join our team and contribute to our mission of saving and improving lives around the world. 

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. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. 

Responsibilities 

• Lead and/or work 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. 

• Manage the IPT deviation management daily huddle to evaluate potential deviations, facilitate discussions to align with technology and quality approvers/representatives on deviation classification and impact assessment. 

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

• Support and/or execute continuous improvement projects that increase compliance, simplify/standardize, and/or gain efficiencies. 

• Manage timelines to ensure key compliance and customer due dates are met; escalate any potential misses and develop remediation plans when possible. 

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

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

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

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

• Collaborate effectively with area Technicians, support groups, and Quality. 

Qualifications 

Required 

• B.S. degree in Engineering or Sciences. 

• 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 less than 1 year experience). 

• Demonstrated ability to drive results. 

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

• Strong problem-solving skillset. 

Preferred 

• Experience in vaccine manufacturing. 

• Experience in sterile processing. 

• Technical writing experience (e.g., investigations, technical protocols/reports). 

• Familiarity with investigative tools (e.g., 5-whys, fishbone). 

• Experience authoring investigations for atypical events in a manufacturing setting. 

• Experience with BSL-2 Processing. 

Required Skills:

cGMP Guidelines, Equipment Troubleshooting, GMP Compliance, Good Manufacturing Practices (GMP), Manufacturing, Personal Initiative, Process Engineering, Production Support, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Sterile Procedures, Teamwork, Technical Writing, Troubleshooting

Preferred Skills:

Deviation Investigations, Mammalian Cell Culture<