Aseptic Technician Assistant, Ridgefield, New Jersey

Job description

****3rd Shift 10pm- 6 am

The Aseptic Technician Assistant performs the tasks of the production operation specific to aseptic cleaning and sterilization of processing equipment, parts and rooms. Maintains batch record documentation and logs as required by corporation and regulatory agencies. Prepares, according to procedures, various stock solutions and buffers as required by the production process. Gown certification will be required.

Responsibilities:

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.

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 carts and onto pallets: moves 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

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.

Basic Qualifications:

High school diploma, and 1-3 yrs experience working in a cGMP environment.

Preferred experience:

Vocational Degree

Prior document revision (SOPs and BPRs) experience

Experience reviewing BPRs

Mechanical experience and working in Aseptic Cleaning and Sanitization 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.

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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.