Aseptic Technician Associate

Job title: Aseptic Technician Associate

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. 

Aseptic Technician Associate will independently perform the tasks of the aseptic manufacturing operation specific to bulk, and fill manufacturing. This includes collection and extraction hyaluronic acid (HA), HA gel manufacturing, Buffer and Saline production, intermediate bulk manufacturing, filling, inspection and packaging process for medical device products along with pharmaceutical based products.  In support of our main functions, additional responsibilities include cleaning and sanitization of aseptic manufacturing facility and 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:

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

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

• 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.

• 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.

HSE

• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.

• The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations.

• Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility.

• Individuals must ensure timely closure of HSE actions owned by their departments.

About You

Skills:

• Perform routine daily and weekly cleaning of manufacturing area.

• Requires good documentation skill and attention to detail.

• Perform to ensure compliance with GMPs and SOPs.

• Will receives instructions on all assignments with some supervision.

• Takes initiative to identify issues, troubleshoot, propose solutions, and keep leads/ management informed.

• Basic computer skills preferred.

Job Requirements:

• Ability to work with aseptic gown up for about 80% of the shift working hours.

• 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.

• Ability to complete tasks and training in a cGMP environment.

• Ability to work in both individual and team environment.

• Ability to enter into confined Space. (Approx. 1-2 hr./week) as needed.

Basic Requirements:

• At least High School Diploma with 2 years of related experience in Pharmaceutical Manufacturing with a minimum of 2 year of experience in a GMP regulated environment. 

• 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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