Cardinal Health
Cleaning Validation Engineer
At a glance
Location: US-GA-Augusta Map
Posted: 10/11/2019
Closing: 11/10/2019
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
Cardinal Health
Job description

What Manufacturing Engineering contributes to Cardinal Health


Manufacturing Engineering is responsible for developing manufacturing processes, production floor layouts and associated tools. Reviews new designs for manufacturability. Designs process improvements to reduce product cost, process cycle time and improved product quality.


Job Responsibilities:

  • Responsible for technical support and life-cycle management of the cleaning validation program
  • Maintains a qualified state of cleaning processes and procedures, as well as designing and implementing new cleaning processes.
  • Maintains the site cleaning validation master plan
  • Conducts risk assessments of existing and new processes, equipment, etc. as it relates to cleaning procedures/validation
  • Designs and executes cleaning process optimization studies, cleaning verification and cleaning validation studies
  • Manages, schedules, coordinates, and executes cleaning engineering studies to optimize cleaning procedures, cleaning verification studies, and cleaning validation studies
  • Designs and develops equipment cleaning procedures
  • Prepares and executes cleaning protocols and reports for cleaning development and validation
  • Investigates cleaning failures
  • Supports the periodic review of cleaning validation studies
  • Develops change controls for implementation of cleaning procedure changes as needed
  • Trains manufacturing and QC personnel on cleaning validation protocols and procedures

ESSENTIAL FUNCTIONS:  

  • Understanding of cleaning validation principles, including calculations of cleaning limits, equipment swabbing, and continued cleaning process verification within a pharmaceutical or medical device manufacturing environment.
  • Understanding of FDA regulations surrounding the manufacture of pharmaceutical products, medical devices, and GMPs
  • Experience with change control documentation packages
  • Excellent technical writing skills with a thorough understanding of good document practices.
  • Experience with manufacturing environment and automated machines. Pharmaceutical experience is considered a plus.
  • Knowledge of modern computer programs to include project management software. Strong Computer skills & MS office suite (Excel, Word, Project, etc.)
  • Ability to express ideas both in written and oral communications.
  • Ability to coordinate with different people who have different priorities and agendas to accomplish the task at hand.
  • Ability to deal with contractors in order to assist them with the equipment process commissioning. 
  • Excellent interpersonal and reasoning skills.
  • Follows all certified standards, GMP, OSHA, plant policies and procedures
  • Sets the standard for timeliness, work ethic, and personal integrity
  • Positive attitude, result-oriented person.
  • Ability to manage multiple task in a high paced environment and willing to adapt and address scope changes.

MINIMUM REQUIREMENTS:

  • Education required/ preferred: B.S. in Engineering (Chemical, Bioengineering, Biomedical, or Mechanical) or BS in Life Sciences (Chemistry, Biology, Biochemistry)
  • Experience: Five to Eight years of experience, preferably in a pharmaceutical manufacturing industry with cleaning validation experience.  Understanding of FDA regulations surrounding the manufacture of pharmaceuticals and/or medical devices and GMPs.
  • Preferred Skills/Qualifications: Experience using Microsoft Office Software
  • Skills/Competencies: Ability to express ideas both in written and oral communications.

What is expected of you and others at this level

  • Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
  • May contribute to the development of policies and procedures
  • Works on complex projects of large scope
  • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
  • Completes work independently receives general guidance on new projects
  • Work reviewed for purpose of meeting objectives
  • May act as a mentor to less experienced colleagues

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Cleaning Validation Engineer