Validation Engineer

Employer
AbbVie
Location
Lake County, IL, US
Posted
Oct 15, 2019
Ref
1906670
Required Education
Bachelors Degree
Position Type
Full time
  • Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
  • Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
  • Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended
  • Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy
  • Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation
  • May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
  • May lead, author, or review investigations and implementation of preventive and corrective action


  • Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering)
  • 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
  • Strong verbal and written communication skills
  • Solid problem solving and analytical skills
  • Solid interpersonal skills, including ability to negotiate/influence without authority
  • Ability to supervise junior or contract team members (prior supervisory experience preferred)
  • Ability to manage complex projects and multiple projects (5+) simultaneously
  • Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferre d