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QMS & SAP Validation Analyst (Contract)
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Kashiv Biosciences LLC
Piscataway, NJ (In Person)
$145,600 Salary, Full-Time
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Job Description
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 forMasterControl 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 protocolsExperience:
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 deviceSpecialized 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.