Senior Process Development Engineer- Packaging Equipment

Amgen • New Albany, OH

208d • 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.

Requirements

• Doctorate degree OR Master's degree and 2 years of GMP regulated environment experience.
• Bachelor's degree and 4 years of GMP regulated environment experience.
• Associate's degree and 8 years of GMP regulated environment experience.
• High school diploma / GED and 10 years of GMP regulated environment experience.

Nice To Haves

• Knowledge of combination product assembly equipment and applicable testing.
• Excellent written and verbal communication skills.
• Proven track record of leading and executing cross-functional projects.
• Direct experience with the manufacturing process for devices, combination products, and label & packaging operations.
• Experience working with Final Drug Product equipment suppliers.
• Ability to work in a highly regulated and ever-changing industry.
• Operational Excellence approach to work product.

Responsibilities

• Support the development and implementation of automated and semi-automated combination product assembly equipment initiatives.
• Manage and apply extensive technical expertise in the assembly of combination products.
• Apply advanced engineering principles to process optimization, scale up, and manufacturing support projects.
• Support the Technical Transfer of the Amgen product portfolio.
• Provide technical operations support for continuous improvement of device assembly and packaging line capacity and performance.
• Act as the site technical expert for automated and semi-automated device assembly.
• Lead the Commissioning, Qualification, and Validation of process and GMP equipment.
• Own the site master validation plan for GMP equipment.
• Support the delivery of productivity, throughput, and general capacity improvements across the New Albany site.

Benefits

• Comprehensive employee benefits package including health and welfare plans.
• Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Master's degree