2+ years validation experience in gmp regulated environment
5+ years overall testing experience
Experience leading software validation projects
Amgen harnesses the best of biology and technology to fight the world's toughest diseases and make people's lives easier, fuller, and longer
Job Summary
Amgen harnesses the best of biology and technology to fight the world's toughest diseases and make people's lives easier, fuller, and longer.
The Validation Lead will oversee and manage validation activities for data platforms and solutions while collaborating closely with cross-functional teams.
Candidates must ensure that data and analytics products follow required validation processes, documentation, and comply with Amgen's standard operating procedures.
Matching Summary
Amgen harnesses the best of biology and technology to fight the world's toughest diseases and make people's lives easier, fuller, and longer.
Skills & Requirements
Must-have
2+ years validation experience in GMP regulated environment
5+ years overall testing experience
Experience leading software validation projects
Proficiency in IQ OQ PQ protocol development
Strong problem-solving and analytical skills
Nice-to-have
Experience with automated computer-controlled systems validation
Knowledge of 21 CFR Part 11 regulations
Ability to work effectively with global virtual teams
Strong presentation and public speaking skills
High degree of initiative and self-motivation
Key Requirements
Bachelor's or Master's degree in Computer Science or Engineering preferred
2+ years of experience in validation within GMP regulated environment