Engineering, Specialist, Technical Operations – (West Point Site Deviation Management support)

Job Description

West Point Technical Operations is seeking highly motivated individuals to provide engineering technical support within manufacturing facilities on the West Point site. The focus of the role includes Deviation Management, including Process and Environmental Monitoring Deviation investigations, with the potential for additional areas of responsibility/development depending on the area supported. The deviation management role includes investigation of process deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing).  The other areas of responsibility offer opportunity for further development and rotation to gain experience in different potential functional roles within Technical Operations. Limited additional shift or weekend coverage may be required based on specific assignments. 

Individuals selected for this role will spend at initial period of time training and/or gaining deviation management experience within the Deviation Management team prior to movement to an area on the West Point site requiring Deviation Management support.  

The individual in this position will be responsible for the following:

• Performing deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.  Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc. 

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

• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations. 

• Collaboration across IPT functional areas to drive robust processing and continuous improvement.  Continuous improvement may include proactive process improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve yield, reduce cost, or lower cycle times. 

• Supporting team and IPT safety, environmental, and compliance objectives. 

• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible. 

• Actively using and championing the use of company Production System (MPS) tools, both in problem solving and day-to-day operational activities. 

• Authoring and updating technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation 

• Authoring notifications to applicable Health Authorities, in response to deviations or complaints, as required. 

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

• Provides technical support to manufacturing for complex problems and issues including process/equipment. 

• Collaborates effectively with the area Biotechnicians/Operators/Mechanics, support groups, Quality, and Planning. 

Required Education / Experience:  

• Bachelor's degree in chemical engineering, mechanical engineering, biological sciences, or related discipline.  

• Minimum 1-year experience in direct experience or support to vaccine/pharmaceutical manufacturing (Technical Operations, Quality, Operations) 

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

• Investigative tools (e.g. 5-whys, fishbone). 

Strongly Preferred Experience 

• Two or more years of vaccine/pharmaceutical