Inspection and Packaging - Vaccine

Job description

ABOUT THE ROLE:

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Performs production in accordance with volume fluctuation, business need and effective procedures. 

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Responsible for Manufacturing activities in assigned area.

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Identifies all production issues and relays them to the leadership team.

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Works to prepare assigned areas for the oncoming shifts.

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Completes tasks and corresponding documentation as required by cGMP. 

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Position includes responsibilities to hand pack, operate machinery, change over duties, and clean-up functions, to assure a smooth transition between product lines.

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Works with Senior Technicians and Managers to ensure a smooth operation.

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Works to become trained in all assigned training modules. 

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

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Follows all procedures put into effect to ensure your safety as well as the safety of others. 

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Participates in monthly safety meetings. 

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Report all safety issues, concerns, incidents and near misses to the team leadership. 

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Actively participates in safety walk throughs coordinated by the department’s safety team. 

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Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.

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Follows effective procedures to ensure the production of a safe and efficacious product.  Works to understand cGMP’s. 

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Identifies areas of deficiency to the leadership team and offers potential suggestions for improvements. 

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Participates in both deviation investigations when appropriate and implementation plans to ensure a quality product.

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Works with the leadership team to complete deviation investigations and root cause analysis. 

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Works to complete quality documentation (PDR’s, logbooks, etc.) accurately in a timely manner. 

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CFR (code of federal regulations) / PAI inspection readiness.  FDA audit understanding and awareness.

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Participates in team meetings. 

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Actively communicates improvement ideas, issues, concerns, etc. to team members. 

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Participates in cross functional teams where necessary to complete projects in an effective and timely manner.

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Ensures proper process area operation by pre and post run set up and maintenance of equipment. 

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Recommends changes to PDR's, SOPS and SWIs when warranted. 

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Write and edit documents under supervision. 

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Seeks out cross training in other areas whenever possible. 

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Responsible for assisting in writing and assisting incident investigations, CAPA's, change controls, along with assisting the higher tech levels and Principle Investigators with projects.

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All other duties as assigned.

BASIC QUALIFICATIONS

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

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Associates with 1 + yrs in cGMP or Pharmaceutical experience

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Bachelor’s with 0 + yrs in cGMP or Pharmaceutical experience

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Prior or related cGMP or Pharmaceutical experience recommended

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

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

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COVID vaccination is mandatory (fully vaccinated)

THE FINE PRINT 

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For influenza production roles (excluding FFIP roles) : candidate must be able to be receive influenza vaccine which is required for building access

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For aseptic area production roles ( excluding Flu production tech roles) : candidate must be able to obtain and maintain current aseptic gowning qualification

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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.

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

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

The Company believes that facilitating cross-functional development of its employees is extremely important. While posting a job internally does not guarantee that an internal candidate will be selected for the position, it does bring transparency to the hiring process and allows interested employees to inquire about or apply for the position.  

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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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.