Production Technician 3rd Shift Filling

Sanofi•Swiftwater, PA

2d•$20 - $27•Onsite

About The Position

Responsible for working inside the fill area. Performs production in accordance with volume fluctuation, business need, and effective procedures. Complete Aseptic Gowning Qualifications and maintain it throughout employment. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. This role is for a nonexempt employee working in the Filling Department. Their Bi-weekly pay is based on previous experience and education time. Their responsibilities are, but are not limited to: 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. Understands the function of the quality group and works with them to maintain a positive rapport. Delivery: Supports production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs. Completes all assigned training Adheres to all other company time keeping and attendance policies. Ensures proper Aseptic technique is followed Completes all SAP transaction is completed in real time Cost: Executes procedure as documented to avoid deviations. Utilizes OMS appropriately Works to resolve common production issue Involvement: Works to become trained in all assigned training modules. Attends the daily shift change. Trains and orients new team members (at any level) as assigned. Participates and leads team meetings. Understands respect, professionalism and confidentiality.

Requirements

HS diploma or equivalent and 1+ years in cGMP or Pharmaceutical experience
Associate’s with 6+ months in cGMP or Pharmaceutical experience
Bachelor’s degree with no prior experience
Requires good mechanical skills, computer skills and is detail oriented.
Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity.
Proficiency in at least but not limited to three areas of operations or product line.
Must be proficient in at least one of the following areas: Utility Sampling, equipment prep, tank movement OR Must be a qualified trainer in vial wash or debag and SAP
Must have knowledge and access to systems (SAP, Master, SCADA, RT Reports, Labware) OR Must have knowledge and access to systems (SAP, HMI).
All other duties as assigned.

Nice To Haves

Prior or related cGMP or Pharmaceutical experience recommended

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 through the 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
Maintains training for and completes Grade B EM, cleaning, and SAP
Consults schedule and ensures appropriate cleanings are completed.
Training of all new technicians.
Ensures operational area is always adequately staffed.
Strive to become experts in their assigned areas
Works with lead/senior technicians and managers to ensure continuous operation.
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
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.
Understands the function of the quality group and works with them to maintain a positive rapport.
Supports production in accordance with volume fluctuation, business need, and effective procedures.
Completes all assigned training
Adheres to all other company time keeping and attendance policies.
Ensures proper Aseptic technique is followed
Completes all SAP transaction is completed in real time
Executes procedure as documented to avoid deviations.
Utilizes OMS appropriately
Works to resolve common production issue
Works to become trained in all assigned training modules.
Attends the daily shift change.
Trains and orients new team members (at any level) as assigned.
Participates and leads team meetings.
Understands respect, professionalism and confidentiality.