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Aseptic Production Technician (2nd Shift) - Vaccine

Swiftwater, Pennsylvania

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Overview

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.

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Do you have what it takes for a successful career with Sanofi?

  • Courageous
  • Results-driven
  • Proactive
  • Problem-Solver
  • Leadership
  • Team player

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Culture: Play to Win

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    Growth

  • Scientists discussing lab work

    Innovation

  • Doctor using new technology

    Efficiency

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    Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"Working at Sanofi I have a career not just a job."

DAN MOORE Global Project Manager

"Working here I feel valued and empowered to do my best. I am proud to be part of a team dedicated to driving change to help save the lives of our patients."

RAQUEL REYES Biological Sales Program

"Working at Sanofi YOU own your career. Where you go is up to you!"

LUCAS GEORGE Director of Viral Manufacturing - Biologics

Responsibilities

Aseptic Production Technician - Vaccine (2nd Shift)

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 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

Or

  • 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.

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

  • 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/senior technicians and managers to ensure continuous operation.

  • Assists with identification and closure of area irritants.

  • Use and completion of OMS tools

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

  • 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.

  • Utilizes 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.

JOB QUALIFICATIONS:

  • 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 1+ years in cGMP or Pharmaceutical experience

  • Associate’s with 6+ months 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 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.

THE FINE PRINT 

  • The candidate must be able to obtain and maintain current aseptic gowning qualification

  • The candidate must be able to receive the influenza vaccine which is required for building access.

  • This position may be required to be moved or temporarily flexed to another department or building within the FFIP operation due to business needs. Additionally, candidates should expect to work in multiple buildings. Some over-time/off-shift work hours may be required based on business needs. We will attempt to provide as much advance notice as possible, two weeks where applicable if any such change is needed.

  • Must be able to lift up to 25 lbs., and bend/lift/move objects as part of the job.

  • Able to stand for up to 8 hours a day (with occasional breaks)

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.

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