Associate Validation Engineer - Amgen (Hope Valley)
Employment Type: Full-Time
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The Association Validation Engineer will be responsible for, with supervision, the generation and execution of Computer Validation and Data Integrity strategies following standard procedures. They will ensure Validation activities are performed in a consistent and controlled manner to support the manufacture of bulk pharmaceuticals.
- Assist in the coordination of validation activities
- Ensure compliance to Part 11 and Annex 11 activities
- Develop and execute validation protocols/reports
- Generate, review and approve validation documents including: DT, FT/FTF, CRSIQ/OQ, RTM, protocols, reports, etc.
- Participate in Operational Excellence projects
- SOP development, review and approval
- Assist with Change Control assessments
- Deviation initiation/ownership
- Participate in internal and external audits
Associate's degree and 4 years of Validation or Engineering experience
High school diploma / GED and 6 years of Validation or Engineering experiencePreferred Qualifications
- 3+ 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 validation protocols and reports.
- Experience in regulatory inspections and knowledge of current industry standards as they pertain to validation of pharmaceutical or biopharmaceutical processes and data integrity.
- System knowledge and experience with Computerized Systems, Deviations, CAPA and Change Control processes.
- Strong verbal and written communication skills.
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.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
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.
Associated topics: bio, biological engineer, biomechanics, biophysics, bioprocessing, hereditary, neurodegenerative, pain, pharmaceutical, therapeutic
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