Senior Manager - Validation

Career Category

Engineering

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Senior Manager Validation

Live

What you will do

Let’s do this. Let’s change the world. In this role as a leader at Amgen Ohio, you will establish and develop a team of engineers and contractors to perform validation activities for the site. You will lead and coordinate the site validation process for equipment and combination products, and establish procedures for equipment and process validation, as well as validation lifecycle management.

• Manage team to lead and support site validation activities.
• Ensuring the initiation, preparation, and closeout of all validation-related documents and change controls.
• Lead all aspects of the development of the validation plan and strategy, and manage the implementation of C&Q/Characterization and Validation. Validation Lead for all validation projects
• Coordinate business activities and assign business tasks to support activities
• Evaluate proposed changes to validated systems and recommend level of validation required
• Coordinated project management activities for validation projects are within scope and budget.
• Assist with the development of system requirements and specifications to ensure requirements are testable and met.
• Coach and develop team in the proper assessment and execution of validation activities.
• Create, review and approve validation test scripts for compliance with appropriate procedures and policies.
• Site representative for government agency audits

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will have these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of directly related experience

Or

Master’s degree and 4 years of directly related experience

Or

Bachelor’s degree and 6 years of directly related experience

Or

Associate’s degree and 10 years of directly related experience

Or

High school diploma / GED and 12 years of directly related experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above 

Preferred Qualifications:

• 6 + years biotech or pharmaceutical industry experience
• Significant Validation experience on Pharmaceutical/Medical Device Process and Equipment Validation with focus on Combination Products
• Able to facilitate and influence senior team members and partners
• Able to successfully manage workload and timelines
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Strong project management, problem-solving, and analytical skills
• Collaborates and communicates well with others, able to balance divergent inputs from various team members and drive issue resolution. Experience with presenting to regulatory agencies.
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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