Lead Computer System Validation Specialist

2 weeks ago


Raritan, New Jersey, United States S2ssoft Full time
Job Overview

Greetings,

This is Priya from S2SSoft LLC. We are currently seeking a CSV Lead. Below is the detailed job overview. Please share your resume, expected rate, and contact information for further consideration.

Position: CSV Lead

Location: Raritan, NJ (Hybrid)

Employment Type: Contract

Role Summary:

  • Responsible for the validation of computer systems, including SAP and other manufacturing systems, ensuring compliance with industry standards.
  • Requires a minimum of 10 years of experience in regulated industries, focusing on Computer System Validation, Quality Management, or Business Analysis within GxP applications.
  • Must possess a strong understanding of 21 CFR Part 11 and a Risk-Based Approach, with the ability to guide project teams effectively.
  • Experience in conducting CSV remediation activities, including GxP identification, Gap Analysis, executing test scripts, and preparing documentation.
  • Knowledge of ISO and CFR requirements is essential, along with strong communication skills to interact with stakeholders and facilitate project interactions.
  • Ability to manage multiple GxP projects and provide guidance and training on policies, SDLC processes, and tools.
  • Proficient in project management tools such as JIRA, with the capability to prioritize projects based on identified risks.
  • Must be able to work independently and lead project teams, demonstrating excellent verbal and written communication skills.
  • Previous experience in CSV, regulatory remediation, or due diligence is required, with potential travel to the West Coast.

Key Responsibilities:

  1. Architect and develop solutions for product or project delivery.
  2. Act as a Subject Matter Expert to support project needs.
  3. Ensure continuous knowledge enhancement and adaptation to new technologies to meet quality standards and client requirements.
  4. Build a skilled team through interviews, training sessions, and mentorship.
  5. Gather specifications and deliver tailored solutions based on domain or technology understanding.
  6. Support competency development through market trend analysis and collateral creation.
  7. Recommend initiatives for client value creation and implement industry best practices.


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