Production Technician - Vaccine

Job Title: Production Technician - Vaccine

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. Your job, as Production Technician within our Filling team, will be to work inside the fill area. Perform production in accordance with volume fluctuation,

business need, and effective procedures.

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:

• Must be flexible to ensure staffing for production needs and maintain aseptic qualifications.

• Maintains training for and completes closed system connections and sampling requirements.

• Fully trained to perform non-routine and routine interventions

• Escalates issue to the Lead Aseptic Technician and Managers

• Coordinates movement of bulk product with managers.

• Completes testing of process related filters.

• Performs routine inventories and escalates missing equipment/materials to senior or management.

• Consults schedule on a routine basis and ensure all parts and materials are available.

• Ensures segregation of components.

• Maintains aseptic gowning.

• Completes tasks and corresponding documentation as required by cGMP to ensure document completion (BFRs, logbooks, forms, etc). Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all aseptic materials.

• In on time and attends and participates in Shift Change.

• Must be able to be complete and maintain qualification of utility sampling of WFI, Clean Steam, and DI as required to keep building GMP.

• Participates in production process (SAP, Labware if required, Trackwise, RT Reports, eDoc, HMI, SCADA access, Virtual Standards, etc.).

• Works to resolve all production issues. Understands next steps and works to guide others throughthe process to complete them.

• Works with senior technician and managers to ensure continuous operation.

• Assists with identification and closure of area irritants.

• Use and completion of OMS tools

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• Must be flexible to ensure staffing for changing business volume and needs.

• Maintains training for and completes Grade B EM, cleaning, and SAP

• Performs routine inventories and escalates missing equipment/materials to management.

• Consults schedule and ensures appropriate cleanings are completed.

• Training of all new technicians.

• Ensures segregation of components.

• Performs production in accordance with volume fluctuation, business need, and effective procedures.

• Must be flexible to ensure staffing for changing business volume and needs. Must ensure maintenance of gowning and Physical dexterity.

• Completes tasks and corresponding documentation as required by cGMP to ensure document completion (BFRs, logbooks, forms, etc). Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all aseptic materials.

• Assists with identification and closure of area irritants. ·

Safety:

• Follows all procedures put into effect to ensure your safety as well as the safety of others.

• Participates in monthly safety meetings.

• Reports all safety issues, concerns, incidents and near misses to the team leadership.

• Actively participates in safety walkthroughs coordinated by the department’s safety team.

• Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.

• Follows effective procedures to ensure the production of a safe and efficacious product.

• Utilizes +QDCI boards for Safety issues Quality: · Regulatory audit understanding and awareness.

• Completes Shop Floor Gemba walks. · Ensures document revisions, logbooks, and forms are maintained as the correct revision on the production floor. Understan