Senior Process Engineer - Combination Products

Amgen SA; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen is seeking a Senior Process Engineer for Combination Products in Thousand Oaks, CA. You will support development and implementation of technical solutions across FDP product portfolios, coordinating complex projects and applying advanced engineering principles to process characterization, optimization, and manufacturing support.

You will lead technology transfer, improve device assembly and packaging line performance, and work with suppliers and contract manufacturers within a highly

Qualifications

• Doctorate degree OR Master’s + 2 years of engineering experience OR Bachelor’s + 4 years engineering experience OR Associate’s + 8 years engineering OR High school diploma/GED + 10 years engineering.
• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
• Proven track record of leading and executing cross-functional projects.
• Strong teamwork, interpersonal and communication skills.
• Direct experience with medical devices/combination products and manufacturing processes.
• Experience with equipment suppliers and contract manufacturers.
• Ability to work in a highly regulated and ever-changing industry.
• Ability to learn and adapt to fast-moving environment.
• Operational Excellence mindset and drive for results.

Responsibilities

• Lead and coordinate technology transfer for product to Amgen facilities.
• Support design for manufacturability and performance of FDP products.
• Provide technical operations support to improve device assembly, packaging lines capacity and performance.
• Ensure effective communication across Amgen network with stakeholders and drive technical improvements.
• Act as subject matter expert for FDP products at Amgen facilities.
• Identify required expertise to resolve process challenges and apply technical process knowledge.
• Deliver productivity, throughput and capacity improvements across facilities.
• Engage FDP expertise network for product assembly, labeling and packaging, and support transfer processes.

Skills

Communication

Project management

Cross-functional collaboration

Regulatory understanding

Process optimization

Education

Doctorate + Engineering experience (PhD)

Master’s degree in Engineering

Bachelor’s degree in Engineering

Associate’s degree + 8 years experience

High school diploma / GED + 10 years engineering

Tools

Process equipment

Device assembly knowledge

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Senior Process Engineer - Combination Products

What you will do

Let’s do this. Let’s change the world. In this vital role you will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the Final Drug Product (FDP) product portfolio at Amgen network facilities. The position is a key role in the Process Engineering team and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance, validation and alteration of systems, and/or processes. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, optimization, scale up or manufacturing support projects.

Project Management

• Leading Technology Transfer process for product to the Amgen network facilities and support in the design for manufacturability of Amgen Final Drug Products.
• The provision of technical operations support for the continuous improvement of device assembly, packaging lines capacity and performance, and advisory of technical improvement projects.
• Ensure effective communication throughout the Amgen commercial site network with all stakeholders and deliver on technical improvements.

Technical Lead

• Act as the subject matter expert lead for FDP products to Amgen network facilities.
• Provide technical expertise for new process equipment and technology.
• Use technical process knowledge and identify the required expertise to resolve process challenges as needed.

Operational Excellence

• Supporting the delivery of productivity, throughput and general capacity improvements across Amgen network facilities by analyzing, designing, and implementing manufacturing and business process improvements.

Relationships

• Engage a network of FDP expertise across the Amgen commercial and clinical operations for product (device) assembly, label and packaging.
• Leverage this network in support of the technical transfer process, design for manufacturability of new combination products, performance trending of existing combination products, equipment standardization and troubleshooting/process improvements.

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:

• Doctorate degree
  OR
• Master’s degree and 2 years of Engineering experience
  OR
• Bachelor’s degree and 4 years of Engineering experience
  OR
• Associate’s degree and 8 years of Engineering experience
  OR
• High school diploma / GED and 10 years of Engineering

Preferred Qualifications:

Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.

• Proven track record of leading and executing cross-functional projects.
• Strong teamwork, excellent interpersonal and communication skills.
• Direct experience with medical devices/combination products and associated manufacturing process.
• Experience of working with equipment suppliers and contract manufacturers.
• Ability to work in a highly regulated and ever-changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast-moving environment.
• An Operational Excellence approach to work product – driving rapid results.
• Process and Equipment experience.
• A passion to deliver excellent work product, develop others with an infective positive attitude!

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, 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, 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.

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.