Validation Specialist

4 weeks ago

Raleigh, United States Lorven technologies Full time
Job DescriptionJob Description

Position: Validation Specialist

Location: Raleigh, NC

Job Mode: Contract

Job Description:

Job Summary:

The Validation Specialist will be responsible for the validation of computer systems and processes, ensuring compliance with regulatory requirements. This role will involve significant interaction with data analytics and RIM to support and enhance our compliance and validation activities. The ideal candidate will have a strong background in validation processes, data analytics, and regulatory information management.

Key Responsibilities:

  • Validation Processes:
  • Develop and execute validation protocols (IQ/OQ/PQ) for computer systems and software applications.
  • Conduct risk assessments and create validation master plans in accordance with regulatory guidelines.
  • Ensure all validation activities comply with GxP, FDA, EMA, and other relevant regulatory standards.
  • Data Analytics:
  • Utilize data analytics to monitor and assess system performance and compliance.
  • Analyze validation data to identify trends, anomalies, and areas for improvement.
  • Provide data-driven insights to support decision-making in validation and compliance processes.
  • Regulatory Information Management (RIM):
  • Ensure that all validation activities align with regulatory requirements and are documented within the RIM system.
  • Maintain and manage regulatory documentation and records, ensuring accuracy and compliance.
  • Support regulatory submissions by providing validated data and documentation as required.
  • Collaboration and Communication:
  • Work closely with cross-functional teams, including IT, Quality Assurance, Regulatory Affairs, and Data Management, to ensure successful validation activities.
  • Provide training and guidance on validation processes and regulatory compliance to team members.
  • Prepare and present validation reports to stakeholders and regulatory bodies as needed.
  • Continuous Improvement:
  • Identify opportunities to enhance validation processes through the use of data analytics and automation.
  • Stay updated with industry best practices, regulatory changes, and advancements in validation technology.
  • Lead or participate in continuous improvement initiatives related to validation and regulatory compliance.

Qualifications:

  • Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field. A Master's degree is preferred.
  • Proven experience as a Validation Specialist, Validation Engineer, or similar role, with a focus on computer system validation.
  • Strong expertise in Data Analytics, with experience using tools like SQL, Python, R, or equivalent.
  • Experience with Regulatory Information Management (RIM) systems and regulatory submissions.
  • In-depth knowledge of GxP, FDA, EMA, and other relevant regulatory standards.
  • Excellent analytical, problem-solving, and communication skills.
  • Ability to work independently and as part of a cross-functional team.
  • Strong organizational skills and attention to detail.

Preferred Skills:

  • Experience in the pharmaceutical, biotechnology, or medical device industry.
  • Familiarity with quality management systems (QMS) and electronic document management systems (EDMS).
  • Certification in Computer System Validation or related disciplines is a plus.

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