Sanofi Group Aseptic Technician Associate in Ridgefield, New Jersey
**2nd shift- 12pm to 8pm
**Will be gowned up to 6-8 hours per day (Grade A environment)
Aseptic Technician Associate
Independently performs the tasks of the production operation specific to aseptic manufacturing, filling, and packaging. Maintains batch record documentation and logs as required by corporation and regulatory agencies. Performs cleaning and sanitizing of production equipment and classified production space. Prepares, according to procedures, various stock solutions and buffers as required by the production process. Prepares equipment, glassware, filters, etc. required for production. Assists in process and system validation activities as required. Independently performs product sampling, environmental monitoring, or other related activities as directed.
Independently performs routine tasks in the areas of Vials, Formulation, Bulking, Aseptic Fluids and Gels Manufacturing. This includes but it is not limited to Operation of the Vial Filler, loading vials onto the Vial Washer while monitoring critical parameters as per procedures on the vial washer and tunnel, unloading vials from the vial capper and inspecting for defects on the vials, loading the vials onto autoclave racks, adding components to the vial capper while monitoring machine’s critical parameters as per procedures, Bulk Formulation, Vial Sterilization, and Vessel CIP/SIP. This job will also entail transfer of heavy vessels on wheels and autoclave racks on wheels.
Perform routine daily and weekly cleaning of manufacturing area.
Will serve as witness of routine unit operation tasks for batch record signing. Maintains all associated documentation for operations being performed. Will be assigned formal FMEAs, RAs, CAPAs, CCRs, NCRs, and Action Items as needed.
Applies acquired skills while performing the most complex tasks of the position, following established practices and procedures. Demonstrated ability to apply experience to perform equipment troubleshooting, monitor employee activities and to make procedural revisions, as needed. Implements and maintains production schedules based upon intra-departmental information. Perform to ensure compliance with GMPs and SOPs.
Generally receives instructions on all assignments with some supervision. Takes initiative to identify issues, troubleshoot, propose solutions, and keep leads/ management informed.
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, 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 stand for longer periods, bend, squat, and reach.
Ability to lift, push or pull various amounts of weight estimate 30-60 lbs.
Gowning up to 6-8 hours per day (Grade A enviroment)
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 extended day hours and weekend. This role requires frequent work on weekends depending on production demands.
High school diploma, and 1-3 yrs experience working in a cGMP environment.
Prior document revision (SOPs and BPRs) experience and experience reviewing BPRs is preferred.
Prior mechanical experience and experience working as an Aseptic Production operator is preferred.
Typical minimum education and experience required is AA degree in related discipline and experience working in GMP environment is preferred.
Gowning up to 6-8 hours per day (Grade A environment)
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.
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.