Syringe Filling PCU Lead

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.

Syringe Filling PCU Lead

Swiftwater, PA

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.

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Provide the leadership, direction, and oversight of the Line 7 Syringe Filling PCU for B57 Aseptic filling at the Swiftwater site. This position is responsible the 24-hour performance (across all shifts) of the operating unit and team, including safety, quality, supply, and financial results. He or she provides guidance and is responsible for development of a team of managers that have the same focus area.

Team will meet the established strategic vision of FFIP Areas in B57. This Deputy Director is responsible to ensure the manufacturing facilities and equipment within his/her control is properly maintained. The PCU Lead manages ~35-45 team members across 3  addition, this position will verify the continued validated state of all equipment and processes within their assigned area of responsibility.

• Provide leadership and direction to Line 7 Syringe Filling Process Centric Unit (PCU)
• Provide leadership and direction to ensure Deviations, Change Controls, CAPAs, and regulatory commitments are met on time and with the highest standards of quality. Responsible for ensuring assigned areas meet current FDA, International Regulatory Body, and Corporate Quality requirements. Leads audits from an operation side for facilities and process audits
• Provide direction and oversight for the shop floor and is accountable to ensure the highest safety and quality standards are maintained.
  
  Work closely with QA and Maintenance to ensure all issues are addressed real time. Develop effective cross functional relationships to support PCU goals and activities.
• Actively pursues the implementation of best industry practices on Aseptic Processing and implementation of SMS 2.0 processes/ ways of working to drive performance and to increase Filling OEE, improve unit operations success rate and reduce operational costs under the influence of Line
  7. Actively Participates and guides Asset Care/CI /Deviation meetings to ensure compliance with SMS standards. Identify and ensure all required metrics and cycle times are maintained.
• Responsible for special projects including providing assistance and recommendations regarding buildings, equipment, and processes relating to the integration of the manufacturing area. Development of working relationships and strong communication links through all levels of the organization. Provides day-to-day support for the production floor to support completion of short-term projects.
• Provides leadership and establishes departmental objectives to align with site vision for safety, quality, productivity, cost, continuous improvement, and employee involvement. Responsible for ensuring that all associates have what they need to complete…