Senior Validation Engineer will be a member of a small team that provides QA support and decision making for Amgen Thousand Oak's equipment Commissioning and Qualification program. The position has two separate areas of responsibility
1. Technical execution of validation tasks associated with QC analytical instrumentation. The instruments will typically be commercial off the shelf (COTS) but may include other more complex validations as necessary.
2. QA oversight of validation tasks associated with manufacturing process equipment. The primary focus for this role will be biologics production but based on the candidate experience, may include a significant amount of small molecule exposure. Manufacturing facilities span the entire end to end process:
API/Bulk drug substance
Drug product formulation and aseptic filling/tableting
Inspection and packaging
Responsible to troubleshoot and provide advice to clients on basic equipment validation issues within manufacturing facilities and analytical laboratories including data integrity assessments and QA oversight of computerized systems.
Effectively collaborate with lead engineers on an ongoing basis and become actively involved as a project team member with direct accountability for project milestones as they relate to QA deliverables for commissioning and qualification. Projects can range from equipment upgrades to large-scale capital projects and facility construction.
As a QA validation lead, responsible for interactions with Amgen's Corporate Validation network, offering advice on strategic management of the validation program and presenting their work during audits and regulatory inspections.
Drive Operational Excellence initiatives within their work space.
In addition to specific validation activities, will be periodically responsible to take on a role within QA operations when validation schedule permits. Periodic activities will include problem solving, QA contact for GMP Investigations and providing subject matter expert assessments for change control processes.
Master's degree and 3 years of Quality or Validation experience
Bachelor's degree and 5 years of Quality or Validation experience
Associate's degree and 10 years of Quality or Validation experience
High school diploma / GED and 12 years of Quality or Validation experience
Technical knowledge of drug product manufacturing, including Quality Control Laboratory processes. Biotechnology manufacturing process (BDS and DP) experience.
Experience in any of the following disciplines: Cleaning Validation, Analytical Equipment Validation, Validation Master Plans and Periodic Monitoring, Computerized Systems, GMP Change Control, or Facility/Critical Utilities.
Knowledge of Small Molecule API manufacturing.
Project management skills
Skilled at initiation and leading cross-functional teams
Database and spreadsheet application skills
Facilitation and presentation skills
Familiarity with statistical tools and methods
Ability to evaluate compliance issues and interact with regulatory inspectors
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.
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.
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