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Manufacturing Technician I

Company: Stefanini
Location: Hayward
Posted on: June 17, 2022

Job Description:

Stefanini Group is hiring for a Manufacturing Technician I



Exciting opportunity awaits! Let us help you get started. Call Shubham Singh - 248-728-2629 or Email me on Shubham.Singh@stefanini.com



Description:

Primary Packaging (full gowning required)
The Manufacturing Technician I is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable.

Under the general direction of the lead technician and the overall direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area. This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.

The incumbent will perform other duties assigned.

1. Supports all local manufacturing operations.

2. Supply components, small parts, glassware, tubing, etc. to cell culture and purification areas.

3. Operate general production equipment (such as parts washers, autoclave, stir plates, etc.)

4. Complete relevant paperwork following GDP/GMP guidelines.

5. Manually clean all portable equipment and small parts.

6. Participate on Continuous Improvement Teams.

7. Receive and distribute supplies into the production area as necessary.

8. Perform daily cleaning of the production area to maintain in GMP fashion.

9. May perform other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.



List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Must have good written and verbal communication skills and understanding of cGMP regulations.

Familiarity with medical device production equipment including but not limited to autoclave, DP oven and CIP/SIP.

Must be able to read and follow detailed written instructions.

Good interpersonal skills and be able to work effectively and efficiently in a team environment.

This position requires shift, weekend and holiday work. Overtime may be required at times.

The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

Knowledge of basic chemical and biological safety procedures.

May require immunization before performing work within the manufacturing area.



List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Must have good written and verbal communication skills and understanding of cGMP regulations.

Familiarity with medical device production equipment including but not limited to autoclave, DP oven and CIP/SIP.

Must be able to read and follow detailed written instructions.

Good interpersonal skills and be able to work effectively and efficiently in a team environment.

This position requires shift, weekend and holiday work. Overtime may be required at times.

The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

Knowledge of basic chemical and biological safety procedures.

May require immunization before performing work within the manufacturing area.



Education and experience that is necessary to perform the job satisfactorily.

Requires high school diploma or equivalent with 0-2 years related manufacturing experience.

The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Repetitive work for long periods, typically sitting. Very good manual dexterity is required. Ability to bend and to lift up to 35#.

Must be able to work in a class 7 clean room following gowning and related guidelines. A variety of chemicals are used in the production areas routinely. Assembly and inspection of small components and materials with limited visual contrast REQUIRES vision to be correctable to 20/20.

The work environment characteristics described are representative of those that an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Ability to work closely with others in high demand situations. Every employee is responsible for performing his/her job safely and for calling to managements attention of unsafe conditions, practices, or equipment. May require overtime to meet production schedule. This job also involves hazardous materials and hazardous waste responsibilities which include understanding and complying with hazardous materials and hazardous waste regulations for job duties such as: proper handling, storage, hazardous waste in-house treatment using neutralization and dilution systems, and labeling requirements for hazardous materials and hazardous waste.

Keywords: Stefanini, Hayward , Manufacturing Technician I, Professions , Hayward, California

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