- Plan, coordinate,and executevalidation activities, including qualification and validation of data products and software applications.
- Developvalidation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reportsand get reviewed and approved
- Ensure validation strategies meet regulatory requirements and company standards
- WriteInstallation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documentsand get reviewed, and approved
- 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, anddata engineeringteams 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.
- Ensuretimelyand effective completion of all validation activities in line with projectobjectivesand schedules.
- Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management.
- Identifyopportunities for process improvements in validation activities.
- Stay current onnew 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 1 - 3 years of experience in Business, Engineering,ITor relatedfield OR
- Bachelor s degree with 2 - 5 years of experience in Business, Engineering,ITor relatedfield OR
- Diploma with 6 - 8 years of experience in Business, Engineering,ITor related field
Functional Skills:
Must-Have Skills:
- 2+ years of experience in validation in aGxP-regulated environment (pharmaceutical, biotech, medical devices, etc.)
- Experienceof working insoftware validation projects
- Strong experience on tools like ALM, JIRAetc
- Must have worked in Agile orSAFeprojects
- Experience with automated and computer-controlled systems validation (21 CFR Part 11)
- Proficiencyin developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation
- Candidate must be able to write validation scriptsin ALM and execute them independently
- Experiencewith 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 depthknowledge 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 orSAFecertified
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
