Manufacturing Technician I
Company: Stefanini
Location: Hayward
Posted on: June 17, 2022
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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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