22 days old

Senior Validation Engineer

Amgen
Woburn, MA 01801
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  • Job Code
    121696643
Amgen

Job ID: R-101984
Location: Woburn, MA, US 01806

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.

As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and a steadfast focus on safety, quality, and compliance.

This role of Sr. Validation Engineer for AWM will lead the development and execution of Computer Validation and Data Integrity strategies, ensure Validation activities are performed in a consistent and controlled manner, and manage/oversee work of contract resources to support the manufacture of bulk pharmaceuticals with minimal supervision.

Responsibilities:
  • Develop validation strategies and project estimation for large scope capital projects, system replacements, and system upgrades.
  • Oversee the generation and execution of validation plans, protocols, and reports.
  • Oversight of required validation documents including: DT, FT/FTF, CRSIQ/OQ, RTM, protocols, reports, etc. for project delivery.
  • Ensure compliance to Part 11 and execute Data Integrity activities.
  • Ensure alignment with regulatory guidelines and industry standards.
  • Develop and manage Operational Excellence (OE) projects.
  • Change Control assessments and management.
  • Deviation/CAPA initiation/ownership.
  • Participate in quality risk assessments for automation and equipment (QRAES).
  • Participate and present in internal and external audits.
  • Coordination of activities between Amgen teams (Manufacturing, F&E, Automation, QC, etc.).
  • Management of contract resources for small and large scope validation activities.


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Validation or Engineering experience

OR

Bachelor's degree and 5 years of Validation or Engineering experience

OR

Associate's degree and 10 years of Validation or Engineering experience

OR

High school diploma / GED and 12 years of Validation or Engineering experience

Preferred Qualifications:

  • 8+ 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 testing 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.
  • Experience 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.


We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

Join Us

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.



PI121696643
Posted: 2020-07-18 Expires: 2020-08-19

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Senior Validation Engineer

Amgen
Woburn, MA 01801

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