Biotech Manufacturing Engineer I

BioSpace; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Discretionary bonus

Stock-based incentives

Flexible work model

Job summary

Amgen in Thousand Oaks seeks an Engineer I to support manufacturing activities and ensure equipment reliability within a cGMP framework. You will collaborate with Automation, Maintenance, Project Management, and Quality Assurance to drive safety, quality, and efficiency in capital projects and operations.

Ideal candidates have a relevant engineering degree with broad manufacturing exposure and a track record of leading continuous improvement in regulated environments.

Qualifications

• Masters degree
• OR
• Bachelor's degree and 2 years of engineering and/or manufacturing experience
• OR
• Associates degree and 6 years of engineering and/or manufacturing experience
• OR
• High school diploma / GED and 8 years of engineering and/or manufacturing experience

Responsibilities

• Model leadership behaviors to create a positive working environment.
• Be accountable for equipment performance and reliability.
• Be accountable for assigned results on key capital projects.
• Suggest design modifications to address risks and quality/safety.
• Provide oversight for verification work by outsourced staff.
• Act as a liaison between Engineering, Automation, Maintenance, Instrumentation, and Quality Assurance.
• Ensure validation protocols are executed per cGMP and safety practices.
• Ensure safety during commissioning, validation, maintenance and manufacturing activities.
• Initiate and drive continuous improvement projects to completion.
• Participate in multidisciplinary site teams when required.
• Support Lean Transformation and process improvement initiatives.
• Provide ad hoc technical support to manufacturing and maintenance.
• Mentor project teams using risk-based approaches.
• Defend equipment calibration/maintenance/validation during inspections.
• Participate in internal audits with QA.
• Assist in developing and maintaining business metric performance.

Education

Master's degree

Bachelor's degree in engineering

Associates degree

High school diploma / GED

Job description

Amgen in Thousand Oaks seeks an Engineer I to support manufacturing activities and ensure equipment reliability within a cGMP framework. You will collaborate with Automation, Maintenance, Project Management, and Quality Assurance to drive safety, quality, and efficiency in capital projects and operations.

Ideal candidates have a relevant engineering degree with broad manufacturing exposure and a track record of leading continuous improvement in regulated environments.