Computer System Validation Engineer at Perrigo

Posted in General Business 16 days ago.

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Location: Grand Rapids, Michigan

Job Description:


Quality • Allegan, Michigan

Prepare and coordinate validation events in conformance with cGMP and FDA requirements. Prepare and/or review validation plans, protocols and reports along with other deliverables associated with validation activities.
  • Reviews technical documents to ensure that validation acceptance criteria are consistent with specifications.
  • Prepares and/or reviews deliverables associated with validation activities.
  • Ensures that validation events occur in conformance with approved procedures.
  • Assesses deviations and recommend corrective actions as necessary
  • High level of analytical skills with proven problem-solving ability, and excellent interpersonal skills.
  • Demonstrated ability to organize multiple tasks and to change priorities to meet project deadlines.
  • Working knowledge of electronic record and signature regulations applied to computer systems.
  • Ability to write technical documents relating to applications and computer systems of complexity.
  • Demonstrated thorough understanding of validation processes and interpretation and application of FDA and cGMP requirements.
  • Bachelor's degree in Computer Science, Engineering, Programming, or a related field.
  • Two years plus pharmaceutical industry experience preferred.

Equal Employment Opportunity/M/F/disability/protected veteran status.


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