Validation Engineer

Location: Thousand Oaks, CA
Date Posted: 05-11-2017
Day to Day Responsibilities:            
Approval of pre and post commissioning and qualification documentation using EDMQ. Support QA Validation in various areas of the B25 Exit. Provide guidance to contractors for successful right first time documentation. Partner with lead engineers on an ongoing basis and become actively involved as a capital project team member with direct accountability for project milestones as they relate to QA deliverables for commissioning and qualification.
 
Summary:
Validation Engineer will be a member of a small team that provide QA support and decision making for Amgen Thousand Oak’s equipment Commissioning and Qualification program. The position is dedicated to a capital project and 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 self (COTS) but may include other more complex validations as necessary.
2. Oversight and execution of validation tasks associated with analytical laboratory equipment such as autoclaves and temperature controlled chambers.
This individual will be required to troubleshoot and provide advice to clients on basic equipment validation issues within analytical laboratories.
This individual will also be required to effectively partner with lead engineers on an ongoing basis and become actively involved as a capital project team member with direct accountability for project milestones as they relate to QA deliverables for commissioning and qualification.
Other routine activities will include problem solving, Commissioning and Qualification contact for GMP Investigations and providing subject matter expert assessments for change control processes.
 
Basic Qualifications
Doctorate degree and 2 years of directly related experience
OR
Master’s degree and 6 years of directly related experience
OR
Bachelor’s degree and 8 years of directly related experience
OR
Associate’s degree and 10 years of directly related experience
OR
High school diploma / GED and 12 years of directly related experience
 
Preferred Qualifications
Strong technical knowledge of drug product manufacturing, including Quality Control Laboratory processes. Small Molecule and Large Molecule experience is strongly preferred.
• Cleaning Validation
• Aseptic Processing and Sterility Assurance
o Media Fill
o Analytical Equipment
o Steam Sterilization
o Depyrogenation
• Validation Master Plans
• Periodic Monitoring
• Automated systems
• GMP Change Control
• Trackwise experience
Additional knowledge of Small Molecule API manufacturing is strongly preferred.
Project management skills
Skilled at initiation and leading cross functional teams
Database and spreadsheet application skills
Strong written and oral communication skills
Facilitation and presentation skills
Familiarity with statistical tools and methods
Ability to evaluate compliance issues and interact with regulatory inspectors

"This posting is for Contingent Worker, not an FTE"
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