Principal Validation Engineer - Process Development

Career Category

Job Description

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.

Principal Validation Engineer- Process Development

What you will do

Let’s do this. Let’s change the world. In this vital role you will be a key expert leading the Commissioning, Qualification, and Validation (CQV) of critical process systems within our AML operations. Your work will ensure the highest standards in Drug Product and Drug Substance manufacturing, making a tangible impact on global health.

Specific responsibilities include but are not limited to:

• Lead CQV Projects: Manage complex projects involving the planning, design, construction, maintenance, and modification of systems and facilities. Develop and document strategies through master plans, protocols, and technical assessments.
• Innovate Facility Engineering: Apply industry-wide validation knowledge to develop novel engineering and design approaches for our facilities.
• Technical Problem Solving: Provide solutions for challenging validation issues, leveraging both internal expertise and external resources as needed.
• Team Leadership: Oversee and coordinate a team of engineers and technicians, potentially supervising staff or project resources directly.
• Cross-Functional Collaboration: Partner with manufacturing, process development, utilities, facilities, labs, and quality assurance teams to develop requirements for complex process and facility modifications.
• Regulatory Compliance: Develop and present validation strategies and system qualification packages during regulatory audits. Ensure compliance with industry standards such as ASTM-2500E, GMP Annex 1, and FDA Guidelines.
• Risk-Based Validation: Implement risk-based approaches for new or modified process equipment used in sterile product manufacturing, including FMEA, PrHA, HAZOP, and QRAEs.
• Budget Management: Develop and manage budgets for large or complex projects across multiple disciplines.
• Technical Liaison: Serve as the primary technical contact within and outside the organization, making independent decisions on technical matters.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Principal Validation Engineer professional we seek is a collaborative individual contributor leader with these qualifications.

Basic Qualifications:

Doctorate degree in Engineering and 2 years of validation experience

Or

Master’s degree in Engineering and 4 years of validation experience

Or

Bachelor’s degree in Engineering and 6 years of validation experience

Preferred Qualifications:

• Expertise in Validation: Extensive knowledge of the Validation Program Lifecycle, equipment commissioning, and qualification of aseptic filling skids.
• Industry Experience: Proven CQV background in the pharmaceutical industry, specifically with aseptic filling processes (e.g., vial washers, depyrogenation tunnels, isolators).
• Regulatory Knowledge: Comprehensive understanding of regulatory requirements and industry standards (ASTM-2500E, GMP Annex 1, FDA Guidelines).
• Project Management: Experience managing complex projects and leading cross-functional teams. Ability to delegate, motivate, and communicate the vision for the validation program.
• Analytical Skills: Strong problem-solving abilities with the capacity to apply scientific and engineering principles creatively.
• Financial Acumen: Proficient in financial analysis tools and budget management.
• Leadership Skills: Demonstrated leadership, decision-making, and team-building capabilities. Experience managing contractors and vendors.
• Communication Skills: Excellent verbal and written communication skills in English.

What you can expect of us

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, life and 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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

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

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.