Manager, Biologics Continuous Improvement – Vaccines

Job Title: Manager, Biologics Continuous Improvement – Vaccines

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 

This position takes a leadership role in identifying and resolving issues related to manufacturing process equipment and/or automated control systems for Continuous Improvement projects for safety, compliance, delivery, and efficiency that impact the supply of bulk Biologic vaccine products.

This position drives continuous improvement by leading cross-functional teams to support Biologics Manufacturing to ensure the manufacturing process equipment operates as expected. Develop and execute or assist in the execution of commissioning and qualification documentation.

This position requires a high degree of relationship building and communication with operations, engineering, automation, maintenance, quality validation and quality assurance.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing Progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Responsibilities include project scope related to manufacturing process equipment, automated control systems, change control development and execution, commissioning and qualification documentation development and execution, test script and protocol completion activities.
• Collaborate with Automation, Engineering and Maintenance to represent the factory with internal and external suppliers and customers for projects related to automated control systems within Continuous Improvement.
• Become a Subject Matter Expert (SME) on the state of the industry trends for automated control systems. Through continuing education, remain current with industry knowledge, trends, and best practices. As a SME, provide strategic input required to stay competitive in the bulk vaccine manufacturing market.
• Attend L1 +QDCI board meetings to gather and report out on issues / opportunities existing on the shop floor.
• Actively develop, promote, and implement safe work practices to ensure safe working conditions for all employees.

CONTEXT OF THE JOB/MAJOR CHALLENGES

• The Manager, Continuous Improvement will identify, investigate, troubleshoot, and resolve issues that impact the manufacturing process equipment and/or automated control systems including but not limited to Wonderware and Delta V.
• The Manager, Continuous Improvement is tasked with leading change. This position is responsible for collaborating with Operations and is expected to work effectively with other supporting functions such as Quality, Engineering, Automation, Maintenance and Manufacturing Technology.
• The Manager, Continuous Improvement will provide operational and technical input to the Antigen Continuous Improvement Team by direct participation and integration into factory operations. This is accomplished through a high degree of shop floor presence and participation in the focus factory.
• The Manager, Continuous Improvement will serve as the subject matter expert (SME) within the Antigen Continuous Improvement Team for projects related to manufacturing process equipment, PLC programming, HMI development and technical interface with automated control systems.

About You

EDUCATION/EXPERIENCE

• BS or MS in a field related to Engineering, Chemical or Mechanical preferred.
• The individual should have at least 5+ years’ experience in a biotech or pharmaceutical role within the areas of manufacturing, engineering, automation, process development or similar.
• The individual must have an excellent understanding of cGMP requirements and Continuous Improvement methodologies, along with demonstrated excellence in a technical or scientific position.
• Must have excellent written and verbal communication skills, as well as the ability to actively and cooperatively lead cross-functional teams.

Certifications

• AVEVA Wonderware, Delta V, Lean Manufacturing, Six-Sigma, and similar certifications are a plus.