Principal Validation Engineer

    • Amgen Inc
  • Posted 26 days ago | Updated 2 hours ago

Overview

On Site
Full Time

Skills

Project management
System requirements
Test scripts
Pharmaceutical industry
Problem solving
Analytical skill
Issue resolution
Decision-making
Leadership
Biotechnology
Research
Manufacturing
C
Corrective and preventive action
Documentation
Strategy
Management
Auditing
Specification
Expect
Science
Pharmaceutics
FOCUS
Finance
Insurance
Sales
Business intelligence

Job Details

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.

Principal Validation Engineer

Live
What you will do

Let's do this. Let's change the world. In this role you will lead and coordinate Packaging Process Validation, Packaging Equipment C&Q/Characterization, Packaging Components Qualifications, Commercial Support, Process Monitoring, Deviations/CAPA's and Lab Operation for Combination Products.

Key Responsibilities
  • Ensure initiation/preparation and closeout of all validation related documents and change controls
  • Overseen development of Validation Plan and Strategy
  • Manage C&Q/Characterization and Validation execution
  • Align Strategy and responses for internal audits on Packaging Equipment's validation Protocol and Plans
  • Act as a Validation Lead for all validation projects
  • Coordinate business activities and assign business tasks to support executions
  • Evaluate proposed changes to validated systems and recommend level of validation required
  • Led all aspects of project management activities for validation projects process within the scope of an overall system project
  • Assist with the development of system requirements and specifications to ensure requirements are testable and met
  • Implement or coordinate the execution of validation plans and validation documents;
  • Coach the implementation teams in the proper execution of validation documents;
  • Preapprove test scripts before they are executed and approve after they have been executed.
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 possess these qualifications.

Basic Qualifications:
Doctorate Engineer or Science degree & 2 years of directly related experience

OR

Master's Engineer or Science degree & 4 years of directly related experience

OR

Bachelor's Engineer or Science degree & 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

Preferred Qualifications:
  • 6 + years biotech or pharmaceutical industry experience
  • Validation experience on Pharmaceutical Packaging Process and Equipment Validation with focus on Combination Products
  • Able to facilitate and influence senior collaborators 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 partners and drive issue resolution
  • Ability to operate in a matrixed environment with site, functional, and executive leadership
  • Experience driving decision making by using DAI principles
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.

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.
  • 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 and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination

Objects in your future are closer than they appear. Join us.
careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.