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.

Specific responsibilities include but are not limited to:

• 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.

 What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Process Development Engineer professional we seek is a collaborative and technically strong individual contributor with these qualifications.

Basic Qualifications:

• Master's degree in Engineering

OR

• Bachelor's degree of Engineering and 2+ years of relevant experience.

Preferred Qualifications:

• 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.

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.

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 & 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. 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

Sponsorship for this role is not guaranteed.