Engineer Process Development Environmental & Contamination Control

BioSpace; West Greenwich (RI); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental and vision insurance

Life and disability insurance

Stock-based long-term incentives

Flexible time-off

Job summary

Amgen Rhode Island site seeks an Engineer in Process Development Environmental & Contamination Control to join a matrixed team supporting commercial programs. You will provide technical support for transfer, qualification, monitoring, and deviations with a focus on ECC across multiple manufacturing lines.

The role offers opportunities for career growth, cross-functional collaboration with Manufacturing, Process Development, Quality, and IS, and exposure to a bulk biologics facility.

Qualifications

• High school diploma / GED and 8 years of Engineering or Operations experience OR
• Associates degree and 6 years of Engineering or Operations experience OR
• Bachelors degree and 2 years of Engineering or Operations experience OR
• Masters degree

Responsibilities

• Work with manufacturing, engineering and quality to fulfill objectives for Environmental Contamination Control (ECC).
• Provide real-time technical support to manufacturing to meet schedules and resolve issues.
• Monitor process performance and identify improvement opportunities; suggest troubleshooting strategies.
• Apply engineering principles and design of experiments to investigate processing issues and drive optimization.
• Collaborate with cross-functional partners to support commercial operations.
• Support regulatory and quality activities, including process qualification and change control.
• Stay current with industry and regulatory trends and contribute to global regulatory filings.

Skills

Problem solving

Communication

Presentation

Organization

Collaboration

Leadership

Education

Bachelor's degree in Engineering or Operations

Tools

EBR

DeltaV

CAPA

Change control

Job description

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. 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, 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.

Engineer Process Development Environmental & Contamination Control

What You Will Do

Lets do this. Lets change the world. In this vital role, you will join the Process Development team in a highly matrixed environment supporting commercial programs at the Amgen Rhode Island site. You will work with a cross-functional team of engineers and scientists to provide technical process support for technology transfer, process performance qualification, continued process monitoring, and deviation resolution for both existing products and new product introductions with a primary focus on environmental contamination control. The site operates two multiproduct facilities that manufacture a diverse portfolio of innovative biologic and biosimilar medicines.

This role offers strong opportunities for career growth and professional development. You will strengthen your leadership, teamwork, and communication skills while building influence across Process Development, Manufacturing, Quality, and Information Systems. The position also provides broad exposure to the technical and operational aspects of a commercial bulk drug manufacturing facility.

Core Responsibilities

• Work in partnership with manufacturing, engineering and quality to fulfill key objectives specific to Environmental Contamination Control (ECC).


• Provide real-time technical support to manufacturing operations to meet production schedules and resolve complex process issues.


• Monitor process performance and operational trends, identify opportunities for improvement, and recommend effective troubleshooting strategies.


• Apply engineering principles, statistical analysis, and design of experiments to investigate processing issues and drive process optimization.


• Collaborate effectively with Manufacturing, Process Development, Quality, and other cross-functional partners to support commercial operations.


• Support key regulatory and quality activities, including process performance qualification, continued process verification, deviations, change control, and process validation documentation.


• Stay current with evolving industry, scientific, and regulatory trends and contribute to the review and authorship of relevant sections of global regulatory filings.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a great problem solver with these qualifications.

Basic Qualifications

• High school diploma / GED and 8 years of Engineering or Operations experience OR


• Associates degree and 6 years of Engineering or Operations experience OR


• Bachelors degree and 2 years of Engineering or Operations experience OR


• Masters degree

Preferred Qualifications

• 2+ years of experience in a pharmaceutical or biopharmaceutical environment supporting cGMP-regulated operations, engineering, manufacturing, or quality systems.


• Strong communication, presentation, organization, collaboration, and leadership skills.


• Experience with systems and processes such as EBR, DeltaV, deviations, CAPA, and change control.


• Technical understanding of biopharmaceutical manufacturing processes, including upstream and downstream operations.


• Excellent verbal and written communication skills, with the ability to communicate effectively across technical and non-technical audiences.


• Ability to manage multiple priorities and deliver high-quality work in a fast-paced environment.

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.

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.

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.