Production Technician 3rd Shift Filling

Job Title: Production Technician 3rd Shift Filling

Location: Swiftwater, PA

About the Job

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.

POSITION OVERVIEW

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.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s lives.

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

• 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.

About You

Requirements

Education/experience:

• 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.

• Prior or related cGMP or Pharmaceutical experience recommended

• 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.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.