Production Operator

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

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.

• 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. 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.

About You

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 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).

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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