Production Operator

Job description

**3rd shift eventually (10P-6:30A)- but will start in 2nd shift – (2-10:30P)**

**Required gowning up to 4 hours in an aseptic area**

Job Description: Aseptic Filling Technician

Prefilled Syringe (PFS) Manufacturing is responsible for fill and finish of prefilled syringe products produced on the site. This includes hyaluronic acid (HA) based medical device products as well as pharmaceutical based products. In support of our main functions, additional responsibilities include cleaning and sanitization of process equipment.

Independently performs the tasks of the production operation specific to aseptic manufacturing and filling. 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, environmental monitoring, or other related activities as directed.

Performs routine tasks in the areas of Aseptic syringe filling. This includes but it is not limited to Operation of the HMI's on automated syringe fillers, performing format part changeovers, bulk sampling, troubleshooting equipment issues, loading syringes into the filling machine or E-beam, manual weight checks, while monitoring critical parameters during operation. 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. The majority of the work activities are performed while standing.

• 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

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. Core Work hours are 4am to 2:30pm. This role requires frequent work on weekends depending on production demands.

BASIC QUALIFICATIONS:

High School Diploma or GED and 7-10 years experience required or

AA degree and 5-7 years in a related discipline or

BS degree and 3-5 years in a related discipline.

PREFERRED QUALIFICATIONS:

Prior mechanical experience and/or experience working as a Production Line Mechanic is preferred.

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.