Sr Validation Engineer

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.

Senior Validation Engineer

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of the Chromatography Data Systems (CDS) Product Team working on computerized systems validations (CSV) and GAMP (Good Automated Manufacturing Practice). This vital role ensures Amgen systems remain aligned with industry standards and align with all regulatory requirements.

Roles & Responsibilities:

• Advising clients on how to meet compliance requirements using a risk-based approach.
• Develop validation documentation and standard operating procedures for various GxP applications.
• Develop test protocols that thoroughly test business requirements.
• Provide test execution oversight and assist with deviation recommendations as required, work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements.
• Work with client business functions and domain experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required
• Development of test / validation scripts based on software design and configurations.
• Develop IQ/OQ scripts as required.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

• Doctorate degree OR
• Master’s degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR
• Bachelor’s degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR
• Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience

Preferred Qualifications:

Functional Skills:

Must-Have Skills:

• Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP
• Experience with regulatory agencies – FDA, EMEA, CFDA, and other regulatory agencies
• Proven leadership skills with the ability to multitask and lead multiple validation projects
• Thorough understanding of the principles of GAMP, SDLC methodologies and testing standard methodology.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Expertise with ALM testing and ALM software (HP)
• Expertise in use – Veeva (all modules – CDocs, QMS, RIM, DocuSign, etc)
• Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance.

Good-to-Have Skills:

• Ability to work independently, excellent problem solving and professional written communications skills.
• Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets, Salesforce, Tableau a plus
• FDA Audit experience a plus & working with regulatory agencies
• Experience with enterprise CDS platform software (Empower/Chromeleon/Unicorn)

Soft Skills:

• Excellent leadership and team management skills.
• Strong transformation and organizational change experience.
• Ability to work effectively with global, virtual teams.
• Excellent analytical and solving skills.
• Ability to prioritise successfully.
• Strong presentation and public speaking skills.
• Strong verbal and written communication skills.
• High degree of initiative and self-motivation.

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 driven and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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.