Fill LL-3 - Vaccines

Company: Sanofi Group
Location: Swiftwater
Posted on: January 25, 2023

Job Description:

**Summary of purpose/major responsibilities**

Responsible for performing area/ shift training needs. Performs assignment of modules and training in accordance with business need, and effective procedures.

**Context of the job/major challenges**

+ FDA audit understanding and awareness. Ensures process in areas is always following proper procedures. Completes Shop Floor Gemba as needed.

+ Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all materials.

+ Ensures routine audits of area are completed.

+ Executes procedure as documented to avoid deviations.

+ Responsibly uses material in an efficient manner to reduce waste.

+ Utilize Operating Management System (OMS) tools in place to ensure efficient processing.

+ Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.

+ Works to resolve common production issues related to area of work.

**Dimensions/Scope**

**POSITION OVERVIEW**

**Summary of purpose/major responsibilities**

Responsible for working inside the fill area. Performs production in accordance with volume fluctuation, business need, and effective procedures.

**Key Accountabilities**

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

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

+ Coordinates movement of bulk product with managers.

+ Completes testing of process related filters.

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

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

+ Orders components as needed.

+ Training of all new technicians.

+ Ensures segregation of components.

+ Maintains aseptic gowning.

+ 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.

+ 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 or leads in all aspects of 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.

+ Ensures operational area is always adequately staffed.

+ Strive to become experts in their assigned areas

+ Works with lead technicians and managers to ensure continuous operation.

+ Assists with identification and closure of area irritants.

+ Use and completion of OMS tools

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. Point of contact for training discussions for regulatory and internal inspections.

+ Completes Shop Floor Gemba walks.

+ Point of contact for training initiatives within Filling.

+ Point of contact for all training change control and CAPA action items.

+ 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

+ All other duties as assigned. 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.

+ Utilize OMS appropriately

+ Works to resolve common production issues

**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**

**Education/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.

+ Prior or related cGMP or Pharmaceutical experience recommended

+ HS diploma or equivalent and 2+ years in cGMP or Pharmaceutical experience

+ Associate's with 1+ years in cGMP or Pharmaceutical experience

+ Bachelor's degree

+ Proficiency in at least but not limited to three areas of operations or product line.

+ Must be a qualified trainer in one or more areas. Must be proficient in at least one of the following areas: Utility Sampling, equipment prep, tank movement

+ Must have knowledge and access to systems (SAP, Master, SCADA, RT Reports, Labware).

+ All other duties as assigned.

**_As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities._**

**_According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE._**

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SP

\#LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Keywords: Sanofi Group, Scranton , Fill LL-3 - Vaccines, Other , Swiftwater, Pennsylvania