Technician - GMP Lab - Manufacturing Medical Equipment Job at Ledgent Technology, Irvine, CA

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  • Ledgent Technology
  • Irvine, CA

Job Description

We are seeking a Maintenance Technician to work onsite in Irvine, CA. We have two roles available and involve the following shifts: 5:30AM to 2PM, Sunday to Thursday or Tuesday to Saturday. This job requires some experience with working in a clean room environment. This role is for 18 months and is W2 hourly with Roth Staffing (Ledgent Technologies is a division of Roth Staffing).

The position is 18 months in duration with Roth Staffing and the manager mentioned there is a possibilty it will be contract to hire.


Job Functions
Essential Job Functions
* Support a wide range of engineering activities such as test, check-out, modification, fabrication and assembly; may formulate and propose technical solutions. Perform complex work using drawings, diagrams, written and verbal instructions, layouts or defined plans to perform testing, checkout, and trouble-shooting functions. Responsible for equipment maintenance (e.g, PM, calibration and services). - 65% of time
* Operate a wide range of lab equipment including set-up, clean-up, break-down, and re-assembly. Collect, document, and analyze test data. Perform operational test and identify failure modes on systems and equipment and propose technical solutions. Perform test method validation for equipment and product designs - 20% of time
* Train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback to engineers on procedures - 5% of time
* May build prototypes and prepare feasibility test units, samples, and/or chemical solutions. May design and build simple fixtures; using sketches, CAD, etc. May create and modify drawings and procedures for fixtures, equipment, products, or processes. May initiate ECRs (Engineering Change Request). - 5% of time
Marginal Job Functions
* Other incidental duties (e.g. occasional photo copying or deliveries) - 5%


Qualifications
Education/Experience
* Associate's Degree or equivalent or technical degree/certificate with 4 years previous experience in R&D Lab and/or medical device experience required, OR
* 6 Years related experience required






Required Skills
* Strong written and verbal communication, interpersonal, and relationship building skills
* Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)
* Strong computer skills, including usage of MS Office Suite; and CAD if applicable
* Full understanding of equipment in a lab environment
* Ability to perform complex troubleshooting
* Ability to identify problems and relevant issues in complex situations, assessing using standard procedures
* Ability to use a wider range of manufacturing, test, development or diagnostic equipment; use tools such measuring equipment
* Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
* Knowledge and understanding of statistical techniques and procedures
* Ability to utilize CAD/drafting software (if applicable)
* Knowledge and understanding of ECR software systems (if applicable)
* Ability to draft technical documents (i.e, manufacturing and testing procedures)
* Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to lab and/or clean room medical device manufacturing
* Strict attention to detail
* Must be able to work in an inter-departmental team environment, as well as with colleagues from other departments and represent organization to outside contacts, i.e., vendors
* Ability to provide feedback in a professional, direct, and tactful manner
* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control




Desired Skills and Experience

5-7 year's experience as a technician performing preventative and corrective maintenance required

* Minimum of 1 year of experience performing preventative and corrective maintenance in a clean room setting required

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

Job Tags

Hourly pay, Contract work, Local area, Shift work, Sunday, Saturday,

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