Job Title: Senior Engineer/Reliability Engineer

Location: Thousand Oaks CA

Duration: 12 Months

Description:

Top 3 Must Have Skill Sets:

• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation

• Direct knowledge of design and troubles hooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.

• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)

100% Onsite Thousand oaks

Relocation: Position requires onsite presence, however candidates willing to relocate on their own are welcome to apply.

Ideal candidate: Experience as a process engineer or similar role in equipment ownership. Strong reliability background and independence in problem-solving

Capable of networking with other buildings and teams to implement reliability programs. Tools include Excel, JMP, and basic knowledge of Python (used by the software team)

Examples of solving equipment reliability problems are encouraged. Data analysis and problem-solving skills, Strong communication and collaboration abilities

Preferred industries: Pharmaceutical, biotech, or medical devices. Open to candidates from other industries with strong reliability backgrounds (e.g., aerospace). GMP experience: Not mandatory, but experience in regulated environments is beneficial

Senior Reliability Engineer

Bachelor Engineering process mechanical degree and 5 years of experience

This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The senior engineer works in partnership with the automation, maintenance, and manufacturing teams to develop and oversee the reliability of equipment while driving safety and quality compliance. The engineer will provide data to support business cases and long term strategy.

The Senior Engineer role will provide direct engineering technical support as follows:

• Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.

• Be accountable for manufacturing equipment reliability

• Suggest design modifications to address risks and design in quality and safety.

• Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation

Basic Qualifications

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience