Validation Engineer (Design Group)

5 - 7 years experience  • 

Salary depends on experience
Posted on 03/20/18
Romeoville, IL
5 - 7 years experience
Salary depends on experience
Posted on 03/20/18

Responsibilities

  • Establishes validation standards, develops and executes validation protocols, reports on findings, and oversees resolution of compliance failures or deviation.
  • Develops and maintains validation-related documentation, which may include specifications, SOPs, work instructions, or batch or testing records.
  • Ensures processes, products, equipment, or systems comply with all applicable external regulations or standards.
  • May assist with new equipment purchases or upgrades to existing equipment.
  • May require execution of FATs, SATs, CTPs, IQ's, OQ's, PQ's, PVs and other validation life cycle documents.
  • Document development and field execution of test protocols.
  • Grow and maintain solid client relationships.
  • Perform investigations and troubleshoot issues related to validation.
  • Develop validation plans.

Requirements

  • Minimum 5years of demonstrated experience with validation of pharmaceutical or medical device processes and equipment
  • FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the Pharmaceutical Industry
  • Validation experience in the areas of automation, packaging, cleaning, computer systems, utilities and/or facilities is desired.
  • Candidates need to possess good communication and interpersonal skills and the ability to interact with all levels of management, clients, and vendors.  Strong computer skills are also required.

Education

  • BS Mechanical Engineering, ElectricalEngineering, Chemical Engineering, Biomedical Engineering, or other related ABET certified technical engineeringdegree.

Travel

  • Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.

R001677

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