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Sanofi Group Aseptic Technician LL-2 in Ridgefield, New Jersey

OVERVIEW:

Manufacturing is responsible for formulation, fill and finish of prefilled syringe and vial products produced on the site.  This includes hyaluronic acid (HA) based medical device products as well as pharmaceutical based products. 

Under supervision this position works in the Component Preparation area and operates equipment as required including but not limited to cleaning and preparation of parts for sterilization in accordance with procedural requirements. Activities also include solution (Saline, Buffer, NaOh) manufacturing. In support of our main functions, additional responsibilities include cleaning and sanitization of process equipment.

CORE RESPONSIBILITIES:

  • Under supervision performs the tasks of the production operation specific to aseptic manufacturing and component preparation. Maintains batch record documentation and logs as required by corporation and regulatory agencies. Must be able to perform cleaning and sanitizing of production equipment and classified production space. Prepares equipment, filters, etc. required for production. Assists in process and system validation activities as required. Performs product sampling or other related activities as directed.

  • This job will also entail transfer of heavy vessels on wheels and autoclave racks on wheels. The candidate must be able to apply experience to perform equipment troubleshooting, train less experienced employees, and to make procedural revisions, as needed.

  • Perform routine daily and weekly cleaning of aseptic and classified manufacturing rooms.

  • Serve as witness to routine unit operational tasks for batch record signing. Maintains all associated documentation for operations being performed.

  • Demonstrated ability in the application of requisite skills and applies additional skills and acquired knowledge while following established practices and procedures. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Most of the work activities are performed while standing. 

  • Perform aseptic gown qualification and maintain the gown qualification at schedule interval. Participate the aseptic media simulation at schedule interval as per regulatory requirements.

  • Perform the task of the production operation specific to intermediate aseptic bulk manufacturing (collection and extraction hyaluronic acid (HA) and Aseptic Fluids/bulks and Gels Manufacturing).

  • Demonstrated ability in the application of requisite skills and applies additional skills and acquired knowledge while following established practices and procedures.

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Most of the work activities are performed while standing. 

  • Based on production schedules, random and different start time scenarios may occur, so a very flexible work schedule is required for the candidate. Ability to accommodate production requirements that may require 50+ hour workweeks, including 2nd shift or split shift hours, extended day hours and weekends. This role requires frequent work on weekends depending on production demands.

  • Upon business needs, independently performs routine tasks in the areas of Formulation, Filling and packaging operation.

  • This job will also requires the transfer of heavy vessels on wheels and autoclave racks on wheels.

This is a first shift position. Based on production schedules, random and different start time scenarios may occur, so a very flexible work schedule is required for the candidate. Ability to accommodate production requirements that may require 50+ hour workweeks, including 2nd shift or split shift hours, extended day hours and weekends. This role requires frequent work on weekends depending on production demands.

BASIC QUALIFICATIONS:

  • Ability to offload product off carts and onto pallets; move transfer carts in and out of manufacturing area

  • Ability to stand over intervals of several hours at a time

  • Ability to bend, squat, and reach

  • Ability to lift, push, or pull various amounts of weight

  • Ability to clean and sanitize process equipment and rooms

  • 5 years of related experience in Aseptic Processing in a GMP regulated environment.

  • Strong content knowledge in CGMP/regulatory compliance.

  • High school diploma or GED

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.

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