About Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

About The Role

Role Description:

We are looking for a skilled Senior Validation Analyst to ensure our Master Data Management solutions are of good quality, compliant and GxP validated. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data mastering solutions and pipelines follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. 

Roles & Responsibilities:

• Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications. 
• Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. 
• Ensure validation strategies meet regulatory requirements and company standards. 
• Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. 
• Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. 
• Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and data engineering teams to drive validation activities and meet project deadlines. 
• Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. 
• Ensure timely and effective completion of all validation activities in line with project objectives and schedules. 
• Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. 
• Identify opportunities for process improvements in validation activities. 
• Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies.  
• Collaborate and communicate effectively with the product teams. 
  
  

Basic Qualifications and Experience:

• Master’s degree with 4 - 6 years of experience in Business, Engineering, IT or related field OR
• Bachelor’s degree with 6 - 9 years of experience in Business, Engineering, IT or related field OR
• Diploma with 10 - 12 years of experience in Business, Engineering, IT or related field
  
  

Functional Skills:

Must-Have Skills:

• 6+ years of experience in validation in a GxP-regulated environment (pharmaceutical, biotech, medical devices, etc.)
• Experience of working in software validation projects
• Strong experience on tools like ALM, JIRA etc
• Must have worked in Agile or SAFe projects
• Experience with automated and computer-controlled systems validation (21 CFR Part 11)
• Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation
• Candidate must be able to write validation scripts in ALM and execute them independently
• Experience with computer system validation and software validation is a plus
• Strong problem-solving and analytical skills
• Excellent communication and teamwork skills
  
  

Good-to-Have Skills:

• Understanding of compliance and regulatory considerations in master data.
• In depth knowledge of GDPR and HIPPA guidelines.
• Good to have prior work experience in MDM domain
• Hand son experience on JIRA, Confluence
  
  

Professional Certifications:

• CSV Certified
• Agile or SAFe certified
  
  

Soft Skills:

• Strong analytical abilities to assess and improve master data processes and solutions.
• Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders.
• Effective problem-solving skills to address data-related issues and implement scalable solutions.
• Ability to work effectively with global, virtual teams
  
  

EQUAL OPPORTUNITY STATEMENT

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 with 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.