Senior Specialist, Operations

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

As part of our Company's Vaccine Manufacturing Organization, the Durham team is seeking a highly motivated individual to serve as a day shift Operations Specialist. The Operations Specialist will be an integral member of the operations team with responsibility for direct support of operations on the production floor, batch record review, and problem solving to drive short to long-term continuous improvement initiatives. This position will be expected to support all production steps in the live virus vaccine formulation and filling area including Thaw/Pool/Fill, Lyophilization, and Capping & Inspection.

Responsibilities

• Provides support for all production activities, resolving critical issues on a daily basis to ensure consistent supply | Facilitates real-time root cause analysis to solve routine production and equipment problems

• Assists shift managers in providing leadership to the production floor. Capable of providing primary leadership to team during extended periods of manager absence such as vacations

• Works in an inclusive manner, treating all team members with respect and helping to create a positive and continuously improving work environment within the team

• Possesses basic compliance experience (GMP and Environmental Health & Safety) and is capable of participating positively in both internal and external regulatory inspections

• Executes and manages Operations batch record review within established timelines for release and effectively liaisons with Quality to resolve comments in a timely manner

• Provides technical expertise and oversight on the production floor, including critical processing observation and real-time feedback, understanding the full process requirements (compliance, equipment, regulatory) in order to best understand and resolve production issues

• Facilitates routine meetings and manages metrics as necessary to ensure the team communicates effectively and routinely meets its commitments

• Drives continuous improvements and corrective actions within the team. Works with production floor personnel to develop and implement the counter-measures necessary to improve production and equipment reliability as well as the compliance posture of the team

• Consistently meets commitments including owning and completing formal corrective and preventative actions for the team within defined timelines

• Understands lean principles and applies these concepts to all aspects of the production environment. Recognizes and investigates opportunities for improving the business through financial savings etc.

• Serves as liaison between the team and support groups in resolving day to day issues and in support of various projects and initiatives including the tech transfer of new products

• Works independently and is capable of balancing shifting priorities without introducing disruption to the organization. Capable of working through uncertainty with minimal levels of manager direction

Education Requirement

• Bachelor Degree (science/chemical, mechanical, or electrical engineering preferred)

• Bachelor of Science (B.S.) degree in Engineering (such as Chemical, Mechanical, Bio-Engineering, Bio-Medical Engineering, Industrial Engineering, etc.) or Science Fields (such as Chemistry, Biology, Microbiology, etc.) strongly preferred

Experience and Skills

Required

• Minimum four years relevant manufacturing, technical, or mechanical support role in a high-volume lean operation

• Working knowledge of cGMP and of regulatory requirements as they apply to the vaccine and/or pharmaceutical industry

• Highly motivated with strategic and effective interpersonal, problem solving, and technical skills

• Principled and strong verbal and written communications

• Work in a Team environment collaborating effectively with other team members as well as external stakeholders

Preferred

• cGMP in an aseptic manufacturing environment

• Inventory management and maintenance planning software such as Systems Applications and Products, automated control systems, and electronic batch record systems

• Basic problem solving techniques such as root cause analysis a