Senior Specialist, Engineering

Job Description

Are you a motivated and innovative engineer looking to make a difference in vaccine manufacturing? As a Senior Specialist, you'll play a critical role in providing technical guidance, leading projects, and driving process improvements that enhance customer satisfaction, safety, and compliance. With a focus on problem-solving, collaboration, and results-driven delivery, you'll be part of a dynamic team that's shaping the future of vaccine production.

The West Point Technical Operations organization is seeking a highly motivated individual for a Senior Specialist – Engineering position for our process engineering team.  The successful candidate will have the opportunity to contribute to the performance and results of the manufacturing area by providing technical guidance.  They will anticipate and interpret customer needs to identify and implement solutions.

Responsibilities include the following:

• Provide technical support for vaccine manufacturing at our Company West Point manufacturing facility.

• Support team safety, environmental, and compliance initiatives.

• Apply technical skills to align activities with department, site and franchise objectives.

• Lead and/or work as a team member on continuous improvement projects, complex manufacturing investigations, process improvement and/or validation projects.

• Complete projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.

• Manage project timelines to ensure key compliance and customer due dates are met; escalating when necessary and developing remediation plans when possible.

• Collaborate with cross functional peers on site and above site as required.

• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve manufacturing challenges.

• Monitor the health of the process through continuous monitoring and the annual process review or continuing validation activities.

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

• Provide on-the-floor support of complex operational and technical (process/equipment) issues.

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

• Prepare documentation to support regulatory submission and participates in regulatory inspection activities for the facility.

Minimum Education Requirement and Experience:

• Bachelor of Science (B.S.) degree in Engineering, Sciences, or related field with five (5) years’ experience in GMP manufacturing and/or technical support thereof; OR

• Master of Science (M.S.) degree in Engineering, Sciences, or related field with three (3) years’ experience in GMP manufacturing and/or technical support thereof

Required Experience and Skills:

• Strong problem-solving skills.

• Experience in biologics, vaccine or bulk sterile manufacturing.

• Developed communication, leadership, and teamwork skills.

• Ability to develop innovative solutions for undefined problems to meet the needs of key stakeholders and project sponsors.

• Ability to manage projects to ensure timely delivery of project milestones.

Preferred Experience and Skills:

• Expertise in cell culture, virology, or industrial microbiology.

• Participation in regulatory inspections.

• Understanding of sterile and aseptic processing.

• Strong understanding of process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies/certification.

• Proficient with data analysis and practical statistics.

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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