Engineer - Physical Methods

Amgen; Thousand Oaks (CA); Sur place; USD 88 000 - 119 000; Plein temps

Avantages offerts par ce poste

Stock-based incentives

Retirement and Savings Plan

Flexible work models

Discretionary annual bonus

Résumé du poste

Amgen seeks an experienced engineer to develop and validate GMP physical test methods for vials, devices, and packaging. You will lead method transfer to manufacturing and QA, coordinating cross-functional teams to ensure quality and efficiency.

The role requires strong communication, project management, and experience with validation, quality systems, and data analysis. Travel up to 10% may be required.

Qualifications

• Master’s degree or higher in engineering or related field.
• Strong communication and cross-functional teamwork skills.
• Experience with GMP, validation, and quality controls.
• Proven ability to design, qualify, validate, and transfer test methods.

Responsabilités

• Develop, qualify, validate GMP physical test methods for products and packaging.
• Coordinate transfer of methods to manufacturing and QA teams.
• Lead cross-functional collaborations to meet project timelines.
• Support investigations and CAPA activities for process improvements.
• Provide training on new methods and equipment.
• Travel ~10% to support international locations.

Connaissances

Mechanical Engineering

Biomedical Engineering

Test method development

Quality systems

Formation

Master’s degree

Bachelor’s degree + 2 years of Engineering experience

Associate’s degree + 6 years of Engineering

High school diploma / GED + 8 years of Engineering experience

Outils

SolidWorks

Minitab

PLC/HMI

Vision systems

Description du poste

About Amgen

Career Category Operations Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Together, we compete in the fight against serious disease.

What you will do

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

Responsibilities

• In this vital role you will be responsible for engineering activities required for the development, qualification, validation, transfer and life cycle management of physical GMP test methods for combination products, devices, primary containers, and secondary packaging components.
• The Engineer shall have the ability to work on multiple projects at the same time.
• The work involves design and development of test methods for measuring physical attributed like dimension, force, time, …, and/or for qualitative inspection of components (e.g., visual inspection for defect).
• It includes ideation of test concept, tooling and prototyping fixtures, proof of concept, feasibility and robustness, qualification of test equipment, evaluation of method characteristics, validation and transfer of the test method.
• It would be for new products, processes, tooling or equipment introduction to improve quality and reliability and reduce costs.
• Develop, qualify, validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
• Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
• Implement projects per Combination Product Organization (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
• Provide expert support for investigations as well as new process development required to improve manufacturing operations.
• Coordinate test method development and delivery with selected contractors.
• Ensure that qualification parameters are met for product assembly requirements.
• Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
• Generate procedures necessary to support department and new process equipment.
• Provide expert training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department (i.e. production operator, mechanics, process engineers).
• Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
• Generate/author and own the Test Method documents.
• Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design.
• Perform other duties as required by the Group Manager.
• Follow the requirements, responsibilities, and authority as required.
• Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables.
• Networks internally to ensure alignment, commitment and project objectives and timelines as well as to ensure effective execution of projects.
• Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen.
• Drives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle.
• Excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership.
• Collaborates with other functional leaders to ensure project success, momentum and commitment.
• Proactively identifies issues and/or risks and develops mitigation options to resolve or raise efficiently.
• Assist with CAPAs and change controls for the continuous improvement and lifecycle management of production transferred methods.
• The position will require approximately 10% travel (including international locations).

Basic Qualifications

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

Preferred Qualifications

• M.S. (Or Doctoral) degree in Mechanical Engineer, Biomedical Engineering or closely related fields.
• Excellent written and verbal communication skills
• Ability to work in a highly matrixed team environment
• 2 years of experience in the biotechnology/pharmaceutical industry
• 2 years of experience in equipment, method, and mechanical design
• Technical writing experience
• Experience with SolidWorks (or other 3D-CAD software)
• Experience with combination products and regulatory requirements
• Experience using Minitab (or other statistical software packages)
• Experience with machine controls (PLC, HMI) and vision systems

Benefits and Compensation

• Salary Range 88,281.00USD -119,439.00 USD
• The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted.
• 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.
• Sponsorship for this role is not guaranteed.

Equal Opportunity

Amgen is an Equal Opportunity employer.

We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements.

Please contact us to request accommodation.

Application Deadline

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Additional Information

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

Company Culture

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