Engineer - Thousand Oaks, CA

Minimum Education Required
Bachelors

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps.

Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

What you will do Let’s do this. Let’s change the world.

As a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS-F&E) Analytical Engineering team you will support Clinical and Commercial Drug Substance plant operations. This role provides system owner oversight and lifecycle management of a wide range of devices in multiple production areas such as cell counters, metabolite analyzers, blood gas analyzers, osmometers, spectrophotometers, endotoxin analyzers, TOC analyzers, and filter integrity testers.

The successful candidate will work cross functionally to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities.

• Serve as team lead working with individuals and teams in Analytical, Engineering, Instrumentation, and Manufacturing to support plant operations.
• Lead/support technical root cause analysis, incident investigations, and troubleshooting on a diverse portfolio of analytical systems.
• Perform job plan and preventative maintenance schedule optimization to reduce labor hours required to maintain instruments.
• Own change control records, CAPA records and deviations as it relates to analytical systems.
• Coordinate offsite vendor support and maintenance of equipment service contracts.
• Lead and support new technology introduction and lifecycle replacements of aging equipment by ensuring qualification requirements are met.
• Provide Continuous Improvement initiatives to mitigate potential failures and reduce production delay hours.
• Maintain Data Integrity Assessments with the current Amgen and Industry standards.
• Support staff proficiency by training team members and standardizing best practices.
• Collaborate with Amgen Drug Substance Plant network to enhance knowledge base and identify improvements for implementation at ATO.
• Draft and revise standard operating procedures, forms, and reports.
• Manage spare parts inventory and strategy for level 1, GMP equipment.
• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.

• Direct Manufacturing Support required for Critical Operations.
• 24 x 7 Onsite/On Call as required.
• Trouble shooting Support for analytical instruments in multiple DS plants.
• Analytical Equipment Administration.
• Daily manufacturing and engineering work center team meetings.
• Preventative and corrective maintenance.
• Spare parts management.

What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

• High school diploma / GED and 8 years of Engineering or Operations experience OR
• Associate’s degree and 6 years of Engineering or Operations experience OR
• Bachelor’s degree and 2 years of Engineering or Operations experience OR
• Master’s degree

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills,…