What are the responsibilities and job description for the QMS & SAP Validation Analyst (Contract) position at Kashiv BioSciences LLC?
Job Type
Contract
Description
Position Type: Contractor / Consultant – FTC (6-9 Months with possible extension)
Location: Piscataway, NJ (onsite - physical presence required) – OR – Chicago, IL (onsite - physical presence required)
Reports To: Sr. Director of IT
Rate: $65–$75/hour, not overtime eligible
Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future
Position Summary
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
Position Requirements and Qualifications
Contract
Description
Position Type: Contractor / Consultant – FTC (6-9 Months with possible extension)
Location: Piscataway, NJ (onsite - physical presence required) – OR – Chicago, IL (onsite - physical presence required)
Reports To: Sr. Director of IT
Rate: $65–$75/hour, not overtime eligible
Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future
Position Summary
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
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
- 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
- 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.
- 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.
- No extraordinary noise levels.
- Very unlikely, but can be able to lift at least 20 lbs.
- No extraordinary requirements.
- High-paced demanding environment to meet ambitious project goals.
- Moderate domestic travel may be required.
Salary : $65 - $75