Aseptic Technician II

卡湯晩; Ridgefield (CT); On-site; USD 50,000 - 75,000; Full time

Job summary

A leading global healthcare company is seeking an Aseptic Technician II in Ridgefield, NJ. The role involves aseptic manufacturing processes, maintaining quality documentation, and ensuring compliance with regulatory standards. Candidates should have relevant experience in aseptic processing and be prepared for a flexible work schedule, including weekends.

Benefits

High-quality healthcare

Wellness programs

Parental leave

Qualifications

• Experience in aseptic manufacturing and filling.
• Knowledge of CGMP/regulatory compliance.
• Ability to perform physical tasks including lifting and moving equipment.

Responsibilities

• Perform production operations specific to aseptic manufacturing and filling.
• Maintain batch record documentation and logs.
• Conduct cleaning and sanitization of production equipment.

Skills

Attention to detail

Aseptic processing

Regulatory compliance

Education

High School Diploma + 2 years Aseptic Processing & GMP environment

Bachelor's degree + 1 year Aseptic Processing & GMP environment

Job description

Job Title: Aseptic Technician II

Location: Ridgefield, NJ

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• 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 wheelsand autoclave racks on wheels. 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.

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.

About You

• Leadership Qualifications:Aseptic Technician is expected to act on and demonstrate the Sanofi LEAD competencies:

• Act for Change:Embrace change and innovation and initiate new and improved ways of working.

• Cooperate transversally:Collaborate effectively with peers, stakeholders and partners across

• the organization to positively impact business results.

• Develop People:Take responsibility for developing oneself and others in anticipation offuture business needs.

Job Requirements:

• 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

Education & Experience

• High School Diploma + 2 years Aseptic Processing & GMP environment OR Bachelor's degree + 1 years Aseptic Processing & GMP environment

• Strong content knowledge in CGMP/regulatory compliance.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.