Career CategoryOperations
Job DescriptionEngineer Process Development Environmental & Contamination ControlWhat you will doLet's do this. Let's 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 youWe 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
- Associate's degree and 6 years of Engineering or Operations experience OR
- Bachelor's degree and 2 years of Engineering or Operations experience OR
- Master's 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 usAs 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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 deadlineAmgen 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.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range88,281.00USD -119,439.00 USD
