Thermal Engineering - Lab Engineer

BioSpace

Thousand Oaks (CA)

Ibrido

USD 100.000 - 140.000

Tempo pieno

2 giorni fa
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Vantaggi offerti da questo lavoro

Comprehensive benefits package
Annual bonus program
Stock-based incentives
Generous time-off

Descrizione del lavoro

Amgen is seeking a Thermal Engineering Lab Engineer to support the Thermal Engineering group within Combination Product Operations. The role involves operating and maintaining laboratory testing equipment, coordinating maintenance and calibration, and assisting with equipment validation and thermal shipping qualification activities.

You will work with R&D, QA/QC, Supply Chain, Maintenance, Manufacturing, and Regulatory teams to review protocols, manage changes, deviations, CAPAs, and controlled

Competenze

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

Mansioni

  • Execute laboratory testing in accordance with approved test protocols, operating standards, SOPs, regulatory requirements, and applicable safety procedures.
  • Operate and support laboratory testing equipment, including compression testers, vibration systems, environmental chambers, vacuum systems, and drop testers.
  • Plan, schedule, and coordinate laboratory maintenance activities, including equipment calibration, troubleshooting, preventive maintenance, and vendor visits.
  • Troubleshoot and perform routine maintenance on laboratory equipment to ensure uninterrupted test execution.
  • Collaborate with cross-functional partners (R&D, QA/QC, Supply Chain, Maintenance, Manufacturing, and Regulatory) on protocol review, test preparation, change control, deviations, CAPAs, and controlled documentation.
  • Support engineers with internal experiments and studies by providing guidance on appropriate test methods and execution.
  • Apply engineering and project management principles to support qualification of thermal shipping systems and temperature monitoring devices in compliance with GMP requirements.
  • Coordinate and communicate effectively with internal stakeholders and external vendors to organize maintenance and service activities.
  • Adhere to and demonstrate working knowledge of Amgen EHS&S policies and procedures.
  • Work effectively within Amgens external vendor and contractor management processes.
  • Safely operate forklift equipment as required.
  • Perform physical tasks including lifting objects up to 60 pounds.
  • Lead or support equipment procurement projects and provide regular status updates on vendor performance and project progress.
  • Drive laboratory improvement initiatives to enhance efficiency, reliability, and compliance.
  • Maintain clear, timely communication with the team regarding laboratory equipment status, availability, and issues.

Conoscenze

Laboratory operations
Project management
Cross-functional collaboration
Troubleshooting
Communication

Formazione

Master's degree
Bachelor's degree + 2 years engineering
Associate's degree + 6 years engineering
High school diploma / GED + 8 years engineering

Strumenti

Maximo
SAP
Microsoft Office
CDOCS
Efinity (Ariba)
Smartsheet

Descrizione del lavoro

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Thermal Engineering - Lab Engineer
What you will do

Lets do this! Lets change the world!

This Engineer position is part of the Thermal Engineering group within Combination Product Operations. The successful candidate will support laboratory operations by performing and maintaining compliant testing activities in alignment with GMP, safety, and regulatory requirements. Responsibilities include operating, troubleshooting, and maintaining laboratory testing equipment; coordinating maintenance, calibration, and vendor services; and assisting with equipment validation and thermal shipping qualification activities. This role works closely with cross-functional teams to support testing, change control, documentation, and continuous process improvement, while ensuring timely and transparent communication on equipment status and readiness.

Responsibilities
  • Execute laboratory testing in accordance with approved test protocols, operating standards, SOPs, regulatory requirements, and applicable safety procedures.
  • Operate and support laboratory testing equipment, including compression testers, vibration systems, environmental chambers, vacuum systems, and drop testers.
  • Plan, schedule, and coordinate laboratory maintenance activities, including equipment calibration, troubleshooting, preventive maintenance, and vendor visits.
  • Troubleshoot and perform routine maintenance on laboratory equipment to ensure uninterrupted test execution.
  • Collaborate with cross-functional partners (R&D, QA/QC, Supply Chain, Maintenance, Manufacturing, and Regulatory) on protocol review, test preparation, change control, deviations, CAPAs, and controlled documentation.
  • Support engineers with internal experiments and studies by providing guidance on appropriate test methods and execution.
  • Apply engineering and project management principles to support qualification of thermal shipping systems and temperature monitoring devices in compliance with GMP requirements.
  • Coordinate and communicate effectively with internal stakeholders and external vendors to organize maintenance and service activities.
  • Adhere to and demonstrate working knowledge of Amgen EHS&S policies and procedures.
  • Work effectively within Amgens external vendor and contractor management processes.
  • Safely operate forklift equipment as required.
  • Perform physical tasks including lifting objects up to 60 pounds.
  • Lead or support equipment procurement projects and provide regular status updates on vendor performance and project progress.
  • Drive laboratory improvement initiatives to enhance efficiency, reliability, and compliance.
  • Maintain clear, timely communication with the team regarding laboratory equipment status, availability, and issues.
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.

Basic Qualifications
  • Masters degree
  • OR
  • Bachelors degree and 2 years of Engineering experience
  • OR
  • Associates degree and 6 years of Engineering experience
  • OR
  • High school diploma / GED and 8 years of Engineering experience
Preferred Qualifications
  • Laboratory operations experience preferred, particularly within biotechnology, biomedical, chemical, or mechanical disciplines.
  • Relevant experience in the pharmaceutical or biotechnology industry, with demonstrated success in equipment maintenance, troubleshooting, vendor management, and test execution.
  • Strong organizational, project management, and written and verbal communication skills.
  • Demonstrated capability in technical presentations, issue analysis, and problem-solving.
  • Proven ability to collaborate and communicate effectively with technically and culturally diverse teams, influence stakeholders toward common goals, and deliver high-quality results under aggressive timelines.
  • Ability to manage multiple tasks and priorities concurrently in a fast-paced environment.
Experience With Maximo Work Order Process And EHS&S Requirements.

Proficiency with relevant systems and software, including SAP, Maximo, Microsoft Office (Visio, Excel, Word, PowerPoint), CDOCS, Efinity (Ariba), Smartsheet, and related tools.

What you can expect of us

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, well 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, experience, and qualifications.

In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include

  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans

Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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