Associate Specialist, Manufacturing Automation

Job Description

Our Manufacturing Operations teams are the people who make our products. Working with a “Safety First, Quality Always” mindset, we strive for continuous improvement while ensuring the highest quality of raw materials, intermediates and finished products.

The West Point, PA campus is our company’s largest vaccine manufacturing facility, employing more than 2,000 people. It manufactures bulk and final dosage forms for all our company vaccine products and is expanding to meet future demand.

The Building 50 Live Virus Vaccine Filling Facility project team is seeking a highly motivated individual 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.

Specialist, Manufacturing Automation is responsible for supporting the process automation and IT systems that directly support vaccine manufacturing unit operations while actively participating in and embracing an empowered team culture.

• Provide technical expertise for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, and Automation Installation/Operational qualification.
• Partner with cross‑functional teams 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.
• Diagnose troubleshooting issues, identify trends, monitor processes, administer system updates, query data, train operators, and participate 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 business, technical, and quality representatives within the area of support through the tier process.
• Support process improvement projects and complex manufacturing investigations.
• Support 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) to resolve root causes.
• Develop and manage automation systems standard operating procedures and work instructions.
• Manage assigned system alarms and responses and reconcile them.
• Support regulatory submission preparation and inspections for the facility.

• Bachelor’s degree in Engineering, Science, Information Technology, or related field.
• Associate’s degree in Engineering, Science, Information Technology, or related field with 2 years of experience in process automation or equivalent.
• High School diploma with 5 years of experience in process automation or equivalent.
• Highly developed communication and teamwork skills.

• Experience with PLCs (Allen Bradley Control Logix/Compact Logix, Siemens S7), SCADA, DCSs (Emerson DeltaV), batch reporting software, AvevaPI, ASI/Field/Profibus, and related technologies.
• Networking, virtual machines, database management, and general IT administration.
• Experience in biologics, vaccine or bulk sterile manufacturing facilities.
• Experience with computer system validation and new facility start‑up.
• Experience working in a GxP environment.

• Biopharmaceutical Industry knowledge.
• Deviation Investigations.
• Global Manufacturing experience.
• IT executive management.
• Manufacturing support.
• Pharmaceutical biology.
• Problem…