Senior Specialist, Manufacturing Automation

Job Description

Job Description:

The West Point, PA campus is our Company’s largest vaccine manufacturing facility with more than 2000 employees.  This facility manufactures bulk and final dosage forms for all our Company vaccine products and is growing to meet the vaccine demands of the future.

We are seeking a highly motivated individual to fill an open position to support the start-up of a new vaccine filling & lyophilization facility at the West Point site.  Facility start-up will include design, commissioning, equipment qualification and live virus vaccine drug product process demonstration in support of facility licensure.

The Senior Specialist, Manufacturing Automation is responsible for supporting the process automation and IT (computerized) systems that directly support vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture.  In this role, the Sr. Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Global Engineering Services, Technical Operations, Operations, Quality, Site Automation, and others. 

Position Responsibilities:

·         Provide technical expertise for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, qualification.

·         Partner with cross-functional team to develop automated processes and complete successful qualification of equipment/process.

·         Support successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facility.

·         Author and update technical documents necessary for automated process design, definition, and qualification.

·         Maintain automation systems in compliance with cGMPs.

·         Evaluate automated and information technology systems and develop strategies to optimize and ensure the quality and stability of automation systems through future expansion.

·         Responsibilities include troubleshooting issues, identifying trends, process monitoring, system administration, update documentation, querying data, operator training and participating in deviation investigations.

·         Develop and execute automation change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.

·         Communicate daily with the business, technical, and quality representatives within the area of support through the tier process.

·         Support process improvement projects and complex manufacturing investigations.

·         Lead digital and data integrity initiatives for the project.

·         Provide technical support to manufacturing for complex problems and issues.

·         Develop and assure consistent application of standardized work, engineering, and process tools.

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

·         Develop and manage automation systems standard operating procedures, work instructions.

·         Responsible for assigned systems alarm and responses and reconciliations.

·         Support regulatory submission preparation and inspections for the facility.

Education Minimum Requirement:

·         Bachelor’s degree in an Engineering, Science, Information Technology, or related field