Process Development Engineer

Amgen • Juncos, PR

1d • Hybrid

About The Position

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. 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. Process Development Engineer What you will do Let’s do this. Let’s change the world! In this vital role, you will provide advanced technical support for the development, optimization, scale-up, and transfer of manufacturing processes for biopharmaceutical products. This role operates as a technical contributor within cross-functional teams, applying engineering principles and scientific expertise to support process development activities through commercial manufacturing. The successful candidate will lead technical initiatives, analyze process performance, identify opportunities for improvement, and support technology transfer and process validation activities. This position requires strong problem-solving skills, effective collaboration, and the ability to manage multiple priorities in a regulated environment.

Requirements

• Master's degree in Engineering OR Bachelor's degree of Engineering and 2+ years of relevant experience.
• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Mechanical Engineering, or related scientific discipline.
• Experience supporting process development, manufacturing sciences, technical operations, or process engineering within the biotechnology, pharmaceutical, or related industry.
• Familiarity with GMP regulations and industry guidance.
• Experience with process monitoring, data visualization, and statistical software (e.g., JMP, Minitab, MATLAB, Python, Spotfire, or similar).
• Strong technical writing and presentation skills.
• Proven ability to work effectively in cross-functional and matrixed environments.
• Combination of office and manufacturing floor environments.
• May require occasional off-shift support during critical manufacturing campaigns, technology transfers, or process troubleshooting activities.
• Ability to comply with all site safety, training, and GMP requirements.

Responsibilities

• Lead process development, optimization, and scale-up activities for downstream manufacturing processes.
• Apply statistical tools and data analytics to evaluate process performance and support data-driven decision-making.
• Author and review technical reports, protocols, study plans, and development documentation.
• Support technology transfer activities between development, pilot, and manufacturing facilities.
• Collaborate with Manufacturing, Quality, Regulatory, Analytical Sciences, Supply Chain, and other functional teams to resolve technical issues.
• Support process validation and continued process verification activities.
• Identify opportunities for process improvements that enhance product quality, robustness, yield, and operational efficiency.
• Present technical findings and recommendations to project teams and leadership.
• Ensure compliance with applicable GMP, safety, and quality requirements.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level