Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients

Job title: Filling Components Lead Tech- Vaccines

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.

This is a 2nd shift position. Must be able to work weekends and holidays as needed.

Filling Components Lead Technician will:

Ensure operational area is running as intended to meet all operational goals.  

Ensures the completion of corresponding documentation, data entry, and delivery as required during all vaccine filling equipment processing. Real time review of this documentation.

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 innovative 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:

Safety:

• Follow 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 vaccine filling equipment preparation and sterilization for production is safe and efficient.

• Utilizes +QDCI boards to maintain information and communication clear

Quality:

• FDA audit understanding and awareness.  Ensures process in areas is always following proper procedures

• Identifies deviation occurrences and prevents or aids in investigations and root cause analysis. 

• Participate in completing at least one incident investigation, one CAPA action item, or one change control action item, along with projects.

• Ensures completion and review of quality documentation (electronic records, logbooks) accurately in a timely manner for process area assigned.

• Understands the function of the quality group and works with them to maintain a positive rapport.

• Writes edits and reviews process documentation for completeness. 

• Identifies areas of deficiency and offers suggestions for improvements. 

• Maintains acceptable execution with no emerging negative trends in procedural deviations

Delivery:

• Performs production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs

•  Completes tasks and corresponding documentation as required by cGMP to ensure document completion.

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

• Ensure proper aseptic technique is applied when assembling and disassembling equipment. Must ensure maintenance of gowning and Physical dexterity to complete proper set up of vaccine production and filling equipment so not to impact the safety, quality, and integrity of the product.

• All other duties as assigned. Adheres to all other company time keeping and attendance policies.

•  Ensures all Final Container materials required for production are available prior to need.

•  Ensures the completion of Real Time SAP transactions in an accurate and timely manner to ensure accurate inventory.

Cost:

• Executes procedure as documented to avoid deviations.

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

• 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.

Involvement:

• Works to become trained in all assigned training modules.

• Trains and orients new team members (at any level) as assigned. 

• Leads prep and tank team meetings.  Understands respect, professionalism, and confidentiality.

• Ensures all materials required for production are available prior to need. 

• Follows proper documentation as required by cGMP.

• Has a thorough working knowledge of cGMP’s and works to help others understand. 

• Ensures prep areas are adequately always covered for current shifts and upcoming shifts.

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

• Involved in at least one cross functional team where necessary to complete projects in an effective and timely manner.

• Trainer –Train and guide Personnel in proper work procedures, use of equipment, cGMP’s, safe work techniques and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.

Other

• Must be able to complete and maintain qualification of utility sampling of WFI, Clean Steam, and DI as required to keep building GMP.

• Lead all aspects of equipment preparation area process (SAP, Labware, RT Reports, ishift for work orders submission, 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.

•  Understands the science behind process steps and technology including aseptic processing.

•  Ensures operational area is adequately always staffed.

•  Become expert in their assigned areas 

• Works with managers to ensure continuous operation.

• Maintain yearly aseptic gowning module qualification.

About You

REQUIREMENTS:

• Requires good mechanical skills, computer skills and detail oriented.

• Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity.

• HS diploma and 4+ years in cGMP or pharmaceutical experience.

• Associates degree with 3 + yrs in cGMP or pharmaceutical experience.

• Bachelors degree with 1 + yrs in cGMP or pharmaceutical experience.

• Proficiency in at least but not limited to three areas of operations.

• Must be a qualified trainer in SAP, LIMS and proficient in iSHIF, utility sampling and/or trainer in building main modules.

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 safe 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.