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Kashiv BioSciences LLC
QMS & SAP Validation Analyst (Contract)Kashiv BioSciences LLC • Chicago, IL, United States
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QMS & SAP Validation Analyst (Contract)

QMS & SAP Validation Analyst (Contract)

Kashiv BioSciences LLC • Chicago, IL, United States
7 days ago
Job type
  • Full-time
Job description

Validation Analyst

We are seeking a Validation Analyst to support validation of our Quality Management System (MasterControl) and SAP implementation (QM, Materials Management, Production modules). This role works under the direction of a senior validation lead and partners with Quality, IT, and business functions to deliver validation artifacts in compliance with 21 CFR Part 11, GxP, and EMA expectations.

Essential Duties & Responsibilities

  • Support validation of MasterControl QMS - authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports
  • Support SAP implementation and validation activities across QM, MM, and PP modules, including test script authoring and execution under senior oversight
  • Contribute to risk assessments, data integrity assessments, and change control documentation
  • Liaise with QA, IT, business process owners, and external SAP implementation partners
  • Support periodic review and maintenance of validated state for assigned systems
  • Assist in audit and inspection readiness for MasterControl and SAP

Requirements

Position Requirements and Qualifications

  • Bachelor's degree in Life Sciences, Engineering, IT, or a lab-based role in life sciences with 3+ years of relevant experience; OR Master's degree with 12 years of relevant experience
  • Prior exposure to CSV activities in a GxP-regulated environment
  • Working understanding of 21 CFR Part 11, EU Annex 11, and EMA guidance
  • Experience authoring or executing validation protocols

Experience

  • Exposure to MasterControl QMS (validation, administration, or end-user)
  • Exposure to SAP (any module, ideally QM, MM, or PP) in a GxP environment
  • Familiarity with GAMP 5 principles
  • Experience with ALCOA+ data integrity principles
  • Prior experience supporting enterprise system implementations in pharma, biotech, or medical device

Specialized Knowledge and Skills

  • Familiarity with GAMP 5 principles and risk-based validation
  • Exposure to Caliber LIMS
  • Exposure to SAP (QM, MM, PP) in a GxP context
  • Prior experience and acting as a liaison across IT, Quality, Lab, and ERP (SAP Preferred) and related systems.

Work Environment & Physical Demands

  • This is an on-site position at our Piscataway, NJ location OR Chicago, IL location
  • Must be able to work extended hours or weekend hours, as may be required.

Noise

  • No extraordinary noise levels.

Standing/Lifting

  • Very unlikely, but can be able to lift at least 20 lbs.

Visual

  • No extraordinary requirements.

Stress

  • High-paced demanding environment to meet ambitious project goals.

Travel

  • Moderate domestic travel may be required.
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QMS & SAP Validation Analyst (Contract) • Chicago, IL, United States

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