Vial Filling Process Manager (2nd Shift

About The Job

Job Title:

Vial Process Manager

Location:

Swiftwater, PA

The Vial Process Manager is responsible for overseeing all personnel and operational activities within their assigned shift, ensuring full team adherence to +QDCI standards. This role drives continuous improvement of line performance by leading and supporting strategic projects and initiatives, including thorough investigation of deviations from planned outcomes and the development of robust Corrective and Preventive Actions (CAPA) to prevent recurrence.

The position requires strong leadership, people managing skills, shift flexibility for coverage and project completion, regulatory awareness, and a commitment to producing safe, high-quality aseptic products. This role manages all shift-level processes to meet departmental goals and priorities while ensuring full compliance with regulatory authorities including cGMPs, CBER, WHO, EP, and other applicable regulatory bodies. Key responsibilities include planning and initiating production schedules, coordinating personnel activities across manufacturing teams, and reviewing batch records for accuracy and completeness.

The role carries broad accountability across employee development, counseling, cost reduction recommendations, quality assurance, incident investigations, CAPAs, and departmental budget management. Shift flexibility is required to drive project completion. The position serves as the primary managerial coverage for shift employees and acts as a key liaison for communicating technical issues and process improvements to relevant stakeholders (e.g., IOC, Management Committee, staff meetings).

When required, this role coordinates Maintenance, Metrology, and Validation activities with functional leaders and plays an active role in implementing new equipment and procedures. Deviation management, people development, and Quality Assurance of the Aseptic Processing area are core to this role. A background in Aseptic Processing is strongly preferred. Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs.

In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.

We're 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 peoples lives.

• Production Management Lead and schedule shift operations using eOOE, iObeya, Qualipso, SAP, and Ocularis
• Critical Function Leadership Execute 5W2H analyses, Gembas, MSVs, LSVs, real-time reviews, BFRs, and audits
• Process Improvement & Projects Identify and lead continuous improvement initiatives that enhance performance and reduce waste
• Cross-Functional Coordination Partner with departments to align priorities and achieve +QDCI standards
• PCU Development & Training Support team growth through coaching and training
• Personal Development Pursue professional growth through assigned training and certifications

Safety: Enforce safety procedures, conduct LSVs/MSVs, report incidents, participate in walkthroughs and investigations

Quality: Ensure cGMP compliance, lead 5W2H/deviation meetings, develop CAPA, conduct real-time reviews, maintain Quality relationships

Delivery: Analyze data to drive performance improvements, support production flexibility, follow escalation procedures, review eOOE metrics, ensure timely training

Cost: Drive CI and cost reduction initiatives, minimize deviations, improve operator efficiency, support changeover functions

Involvement: Complete training modules, maintain qualified trainer status, train new team members, lead meetings professionally

Office environment and proper PPE >50% of time; isopropyl alcohol exposure