Computer System Validation Engineer at Perrigo
Posted in General Business 16 days ago.
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Location: Grand Rapids, MichiganJob 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.