QMS & SAP Validation Analyst (Contract)

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 1–2 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.