System Validation Engineer

3 days ago

Middleton, United States Talent Groups Full time
  1. We are seeking a highly skilled and experienced Computer System Validation (CSV) Specialist to support our GxP (Good Manufacturing Practice) and regulatory compliance initiatives. The ideal candidate will have experience with Veeva Systems, 21 CFR Part 11 compliance, and a solid understanding of Project Management methodologies to ensure systems meet the necessary validation and regulatory standards.
  2. Key Responsibilities:
  • Computer System Validation (CSV):
  • Lead and manage validation activities for GxP-compliant computer systems, including the creation, execution, and documentation of validation protocols (IQ, OQ, PQ) for systems like Veeva Vault, Veeva QMS, and other enterprise software.
  • Regulatory Compliance:
  • Ensure all computer systems are in compliance with 21 CFR Part 11, GxP, and other applicable regulatory requirements. Conduct risk assessments and maintain validation status of systems used for regulated activities.
  • Veeva Systems Expertise:
  • Provide expertise in Veeva Vault and Veeva QMS systems, assisting with the implementation, validation, and management of these systems within the context of GxP requirements.
  • Project Management:
  • Lead cross-functional teams to ensure that all validation projects are completed on time, within scope, and in compliance with regulatory guidelines. Prepare detailed project plans, timelines, and resource allocation strategies.
  • Standard Operating Procedures (SOPs):
  • Develop, review, and update SOPs related to computer system validation, change control, and other GxP activities to ensure adherence to quality standards.
  • Documentation & Reporting:
  • Maintain and manage accurate and detailed documentation of all validation activities, including test scripts, validation reports, deviations, and CAPAs (Corrective and Preventive Actions). Ensure documentation meets regulatory standards for audits and inspections.
  • Cross-Department Collaboration:
  • Work closely with IT, Quality Assurance, Regulatory Affairs, and other departments to ensure system validation requirements align with overall business and compliance objectives.
  • Audit & Inspection Support:
  • Support internal and external audits, regulatory inspections, and customer audits by providing validation documentation and answering questions related to system validation processes.
  1. Qualifications:
  • Experience:
  • Minimum of 3-5 years of experience in Computer System Validation (CSV), specifically with GxP-regulated environments. Experience with Veeva Vault, Veeva QMS, or similar systems is highly preferred.
  • Education:
  • Bachelor’s degree in a relevant field (e.g., Computer Science, Life Sciences, Engineering, or related discipline).
  • Regulatory Knowledge:
  • Strong understanding of 21 CFR Part 11, GxP regulations, and other relevant standards (e.g., EU Annex 11, FDA guidelines). Familiarity with ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate).
  • Skills:
  • Strong Project Management skills with the ability to lead cross-functional teams.
  • Excellent communication and problem-solving skills.
  • Experience with Excel, Veeva Systems, and other enterprise software applications.
  • Strong attention to detail and organizational skills.
  • Certifications (Preferred):
  • Certification in Project Management (e.g., PMP or PRINCE2).
  • CSV or GxP training/certification is a plus.

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