Validation Engineer will lead the development and execution of Computer Validation and Data Integrity strategies as well as ensure Validation activities are performed in a consistent and controlled manner to support the manufacture of bulk pharmaceuticals.
Provide leadership and coordination of validation activities
Develop/Update Validation Plans
Ensure compliance to Part 11 and execute Data Integrity activities
Develop and Execute validation protocols/reports
Generate, review and approve validation Documents including: DT, FT/FTF, CRSIQ/OQ, RTM, protocols, reports, etc.
Execute Operational Excellence Projects
Ensure alignment with regulatory guidelines and industry standards
SOP development, review and approval
Provide Change Control Assessments
Participate in quality risk assessments for automation and equipment (QRAES)
Participate in internal and external audits
Coordination of activities between Amgen teams (Manufacturing, F&E, Automation, QC, etc.)
Basic Qualifications :
Bachelor's Degree & 2 years of Validation or Engineering experience
Associate's degree & 6 years of Validation or Engineering experience
High school diploma/GED & 8 years of Validation or Engineering experience
Preferred Qualifications :
5+ years of experience in pharmaceutical or biopharmaceutical environment with cGMP FDA regulated. operations/engineering/manufacturing/quality environment
Technical understanding of pharmaceutical/biotechnology unit operations.
Direct validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, validation plans, protocols and reports.
Experience in regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to validation of pharmaceutical or biopharmaceutical processes and data integrity.
Strong skills in communication, presentation, organization, team development and leadership.
Knowledge of risk-based validation methodologies, such as GAMP5, regulatory agency expectations, and biopharmaceutical processes.
Ability to evaluate compliance issues and interact with regulatory inspectors.
System knowledge and experience with Computerized Systems, Deviations, CAPA and Change Control processes.
Excellent verbal and written communication skills.
Ability to manage multiple complex tasks at one time.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.