Associate Engineer/Sample Preparation

Description:

Onsite support Thousand Oaks site. Candidates within a reasonable commutable distance.

Top 3 Must Have Skill Sets:

Sample preparation

Manufacturing experience

Documentation experience

Ideal candidate: experience over education. able to preparing prototype, someone who has worked in a factory before. tenure in a factory, machines where they fail someone who has experience in implementing in building a new plant or new factory lines. Any regulated industry, not just pharma, A degree in engineering or a physical science would be beneficial. Open to benchwork candidates who have previously done assays, pipetting, etc. open to repetitive tasks and diligently following the SOPs. nice to have: good with written reports, data and feedback.

Amgen Thousand Oaks is in the process of bringing in new automated visual inspection (AVI) equipment into its clinical manufacturing facility.

Under general supervision, the candidate will assist with several critical processes related to setting up this equipment and running extensive qualification studies.

Firstly, the Associate Engineer will follow established protocols to manually prepare glass vial defect kits for running on the system. The defect kits may also be used to support other operations across the company’s manufacturing network.

Secondly, the Associate Engineer will be expected to run tests on a prototype version of the equipment, providing written reports on test data and feedback on system performance and user experience.

The successful candidate should be familiar with preparing documentation, ideally in a GMP manufacturing environment. Experience with qualifying pharmaceutical manufacturing equipment is highly desirable. General experience in operating manufacturing equipment (in any industry) would also be useful.

Beyond the support of the AVI equipment introduction, the Associate Engineer may be invited to support additional technology development projects as bandwidth permits.

A degree in engineering or a physical science would be beneficial.

Basic Qualifications

Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience