Intellectt Inc

CSV Lead

Intellectt Inc Philadelphia, PA
Intellectt Inc

CSV Lead

Intellectt Inc Philadelphia, PA
5 months ago 31 applicants

See who Intellectt Inc has hired for this role

Spark Therapeutics

CSV Lead

Hybrid in Philadelphia, PA (Center City)

2 year contract

Top Skills' Details

  • GMP GXP environment- 8-10+years experience operating as a CSV specialist. This will be a lead position overseeing CSV validation efforts as well as infrastructure support
  • Develop and manage GxP Infrastructure Qualification lifecycle documentation, including Validation Plans, Specifications, Testing Protocols (IQ), Traceability Matrix, SOPs, Change Control, Risk Assessments, and Validation Reports.
  • Infrastructure applications validation
  • Must be able to conduct risk assessments on their own- should have prior knowledge around infrastructure Qualification
  • 21 CFR Part 11 experience- GAMP 5 requirements, as well as Annex 11 Compliance

Job Description

Spark Senior IT Infrastructure CSV Lead

Responsibilities

  • Develop and manage GxP Infrastructure Qualification lifecycle documentation, including Validation Plans, Specifications, Testing Protocols (IQ), Traceability Matrix, SOPs, Change Control, Risk Assessments, and Validation Reports.
  • Conduct Infrastructure Qualification compliance risk assessments in accordance with Spark standard operating procedure.
  • Support Infrastructure Qualification efforts and act as the primary user/sponsor contact for coordinating work, reporting status, resolving issues, and addressing change control requests as they apply.
  • Support complex technical quality requirements in specific IT Infrastructure and CSV situations, such as validation of new systems, upgrades, changes or remediation, etc.
  • Provide guidance, interpretation, and ensure compliance with CSV and IT related regulations, quality manuals, company policies, and procedures.
  • Provide technical input to address validation deviations: providing technical assessments for change requests; identifying qualification/validation requirements to ensure GxP compliance; and performing technical reviews of validation deliverables.
  • Interface with internal stakeholders to analyze data and situations leading to sound decision making.

Requirements

  • Bachelor’s degree in computer science or engineering discipline along with 10+ years of experience in the field of Computer System Validation and IT Infrastructure Qualification in the Pharmaceuticals, Life Sciences, and Healthcare industries.
  • 10+ years’ experience in Good Manufacturing Practice (GMP) / QA within Food and Drug Administration (FDA) regulated environments.
  • Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, GCP, GLP, GMP, QSR, etc.) and internal requirements employing regulatory guidance and industry standards.
  • Working knowledge and the practical application of the following:
  • GAMP 5 risk-based approach to compliant computerized systems.
  • GAMP Good Practice Guide for IT Infrastructure Control and Compliance
  • Experience with FDA 21 CFR Part 11 compliance.
  • Experience with Eudralex, Volume 4 - Annex 11 compliance.
  • Experience in developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC and IT infrastructure phases.
  • Ability to communicate verbally and especially in writing at a professional level and to distill complex technical terms to a layperson's understanding with conciseness, clarity, and accuracy. Excellent writing skills (functional/technical specifications) are required.
  • Strong relationship building skills and ability to work well in a multi-cultural environment.
  • Demonstrates attention to detail and possess strong analytical skills.
  • Ability to multi-task and able to effectively handle multiple priorities / responsibilities.

Local resource preferred.

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Other

  • Industries

    Staffing and Recruiting

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