Computer System Validation Remote Jobs in California

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 Software Engineer

Duties: Lead efforts to design, build, and develop rapid Proof-of-Concept (POC) automated solutions and services; Technical project leadership for cross-disciplinary external projects traversing the areas in Operations, Research & Development, Commercial, Manufacturing and Finance & Accounting Functions; Work with Process Subject Matter Experts (SMEs) to understand key process requirements and transform them into digital automated solutions; Collaborate with business partners to understand how automation can improve workflow, quality, and productivity; Synthesize requirements from clients, customers, or end-users to develop and validated with best automation solutions; Provide clear documentation for delivered solutions and processes; and Work closely with Quality Assurance partners while supporting computerized systems validation processes in a GxP environment. May telecommute.

Requirements: Bachelor's degree (or foreign equivalent) in Mechanical Engineering, Industrial Engineering, or a related field & 5 years of experience in the job offered or in a project management-related occupation. Position requires 5 years in experience in the following:

Gathering and analyzing requirements from business users and translating them into test strategies, test plans, and test scripts;

Perform automation testing using Unified Functional Testing (UFT), Selenium, and Automation Anywhere;

Utilizing programming languages including: Java, C#, VBScript, and VBA for automation;

Supporting and integrating automated testing within CI/CD pipelines, utilizing GitLab and Jenkins;

Implementing projects aligned to organizational GxP processes, including FDA Regulations 21 CFR Part 11, ensuring product quality, data integrity for patient safety;

Participating in and support Computer System Validation (CSV) activities, including creation and maintenance of validation documentation;

Working within Agile methodologies for technology solution development, including participation in sprint planning, backlog grooming, stand-ups, and retrospectives;

Implementing and supporting regulated systems with demonstrated experience in Incident, Problem, and Change Management;

Managing projects throughout the lifecycle and support of solutions in production including root cause analysis (RCA), Corrective Action and Preventive Action (CAPA) and audit activities; and

Maintaining clear, concise, and compliant documentation aligned with regulatory and organizational standards.

Contact: Interested candidates please apply via https://careers.amgen.com/en/search-jobs and search for job # R-248093

Job type: Full-Time position. The annual salary range for this position in the U.S. is $153,130.00 - $181,766.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visithttps://careers.amgen.com/life-at-amgen/benefits/

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.

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.

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 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

• Flexible work models, including remote and hybrid work arrangements, where possible

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

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.