Lab Systems Validation Specialist

1 week 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) Department, overseeing and executing GxP computerized system validation initiatives in alignment with current Good Manufacturing Practices (cGMP), applicable regulations, and industry standards.

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

Key Responsibilities:

  • Provide independent technical guidance and take ownership of comprehensive computer system validation activities.
  • Ensure adherence to quality and compliance standards by applying critical analysis to CSV tasks.
  • Draft, review, and approve foundational documents such as Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), and Standard Operating Procedures (SOPs) to support Computerized System Validation/Assurance efforts.
  • Generate, review/approve, and execute validation documentation (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)) for GxP systems from Quality Control Units.
  • Develop, implement, and maintain controlled documents related to computer system validation to facilitate the initiation, validation, operation, and maintenance of GxP systems.
  • Assist with change controls, Corrective and Preventive Actions (CAPAs), deviations, and exceptions as part of system validation processes.
  • 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 actions on existing computer systems to ensure compliance with applicable regulations.
  • Collaborate with stakeholders and team members to make informed decisions regarding the optimal validation of computer systems, maintaining open communication about system needs and validation status.
  • Work alongside approved vendor personnel to coordinate validation efforts, ensuring successful validation lifecycle management.
  • Regularly review and update department-specific SOPs to reflect the latest regulatory changes and industry best practices.
  • Conduct system assessments following version upgrades or release updates on SaaS/Cloud-based GxP systems, ensuring all required verification and validation activities are performed.
  • Facilitate risk assessments related to computer system validation, including system-level and requirement-level evaluations.
  • Assist in creating business process documentation such as process flows, data flows, user procedures, work instructions, and forms for GxP computerized systems.
  • Conduct periodic system reviews to confirm 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 Life Cycle Validation methodologies and practical knowledge of computer system validation/computer software assurance requirements.
  • Expertise in validating cGMP automation/computerized systems within FDA-regulated environments, with a strong grasp of industry standards and best practices for computer validation.
  • Proven ability to manage multiple projects and priorities effectively.
  • Exceptional written and verbal communication skills.
  • Strong time management and interpersonal skills.
  • Ability to work collaboratively within teams amidst rapidly changing priorities.
  • 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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