Lab Systems Validation Specialist

2 weeks ago


South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

The selected candidate will be an integral part of the IT Computerized System Validation (CSV) Division, overseeing and executing GxP computerized system validation initiatives in accordance with cGMP, CFR Part, and Annex regulations.

This role is crucial in ensuring that GxP systems fulfill their intended purposes and adhere to relevant regulations, contemporary industry standards, and Katalyst HealthCares & Life Sciences' policies and procedures.

Key Responsibilities:

  • Provide independent technical guidance and take responsibility for comprehensive computer system validation activities.
  • Ensure adherence to quality and compliance by applying critical analysis to CSV tasks in line with established protocols and standards.
  • Create, review, and authorize foundational documents such as Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), and Standard Operating Procedures (SOPs) in support of Computerized System Validation/Assurance efforts.
  • Generate, review/approve, and implement validation documentation (IQ, OQ, and PQ) for GxP systems from Quality Control Units.
  • Develop, implement, and maintain controlled documents related to computer system validation to support the initiation, validation, operation, and maintenance of GxP systems.
  • Assist with change controls, Corrective and Preventive Actions (CAPAs), deviations, and exceptions necessary for system validation activities.
  • Support administrative and maintenance tasks for Lab Systems.
  • Contribute to continuous improvement initiatives by monitoring, tracking, and executing steady-state activities for Lab Systems.
  • Conduct gap analyses and necessary remediation on existing computer systems to ensure compliance with relevant regulations.
  • Engage in collaborative decision-making and provide recommendations regarding optimal validation strategies for computer systems, maintaining close communication with stakeholders and team members.
  • Work with approved vendor personnel to coordinate validation efforts, including the review and approval of related validation deliverables, ensuring a successful validation lifecycle.
  • Periodically review department-specific SOPs and update them as necessary to reflect the latest regulatory changes and industry best practices.
  • Perform system assessments based on version upgrades and release updates on SaaS/Cloud-based GxP systems, ensuring all required verification and validation efforts are executed.
  • Facilitate risk assessments related to computer system validation, including system-level and requirement-level evaluations.
  • Assist in developing business process deliverables such as process flows, data flows, user/operating procedures, work instructions, and forms for GxP computerized systems.
  • Conduct Periodic System Reviews to ensure that systems maintain their validated status.
  • Support regulatory inspections and internal audits, implementing corrective actions as necessary in CSV.

Education:

Minimum Required: Bachelor's degree in Engineering, Science, or a related technological field.

Preferred: Bachelor's degree in Pharmaceutical Science, Biomedical Engineering, or Management of Information Systems (MIS).

Experience:

Minimum Required:

  • At least six years of experience in the pharmaceutical industry with GMP exposure.
  • Familiarity with the Life Cycle Validation approach and practical knowledge of computer system validation/computer software assurance requirements.
  • Understanding of cGMP automation/computerized systems validation within FDA-regulated environments, with a strong grasp of industry standards and best practices.
  • Ability to effectively manage multiple projects and priorities.
  • Excellent written and verbal communication skills.
  • Strong time management and interpersonal skills.
  • Proven ability to work effectively within teams in dynamic environments.
  • Demonstrated analytical and problem-solving capabilities.

Preferred:

  • Relevant validation experience with laboratory systems utilized in the pharmaceutical sector is advantageous.

Knowledge, Skills, and Abilities:

Minimum Required: Proficiency in Risk Management Tools, MS Word, Excel, PowerPoint, Visio, Project, and Outlook.

Preferred: Familiarity with TOC Analyzer, LCMS-Sciex, Novatek LIMS, and ValGenesis VLMS.



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