Computer System Validation Specialist

2 days ago


Norton Shores, Michigan, United States Northern Biomedical Research Full time
Job Title: Computer System Validation Specialist

We are seeking a highly skilled Computer System Validation Specialist to join our team at Northern Biomedical Research. As a key member of our QA department, you will play a critical role in ensuring the quality and integrity of our computer systems and processes.

Key Responsibilities:
  • Develop and implement efficient software/computer validation programs for GLP environments
  • Identify computerized systems validation needs through in-house assessments or by coordinating needs assessments with external teams
  • Partner with business and validation teams for site computer validation projects
  • Develop software/computer validation protocols and final reports, as well as coordinate and perform activities per protocols
  • Maintain site Master Validation Schedule and periodically review validated systems
  • Assist QA in auditing vendors of cGMP-related software and hardware
  • Evaluate vendor validations and add company-specific protocols as required to complete validation
  • Provide technical counsel on issues and concerns regarding validation plans and protocol designs
  • Train company personnel as needed on SOPs
Requirements:
  • Minimum: Bachelor's degree or equivalent
  • Experience: 5-10 years' experience in Computer System Validations
  • Knowledge of GxP
  • Level of proficiency necessary for competence in the position as identified by the department training website
  • Knowledge of GLPs (21 CFR Part 11) and other federal regulations relating to information technology
  • Advanced understanding of laboratory operations and data collection
  • Ability to work effectively under time constraints
Behavioral Expectations:
  • Adaptability/Flexibility
  • Conflict Resolution
  • Critical Thinking
  • Resilience
Special Requirements:
  • The person filling this position will spend approximately 80% in an office setting and 20% in the laboratory
  • Exposure to animal pathogens and chemicals
  • Handling of, and/or exposure to animal tissue and zoonotic organisms
  • Ability to don and wear personal protective gear, including N95 masks and respirators
  • Physical Requirements: Ability to lift and carry up to 50lbs. Occasionally ascend/descend ladders and stairs
  • Ability to work beyond typical work schedule, including evenings, weekends, extended shifts with short notice


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