QMS & SAP Validation Analyst (Contract)

Kashiv Biosciences LLC; Piscataway Township (NJ); On-site; USD 89,544 - 103,320; Full time

Job summary

Kashiv Biosciences LLC is looking for a Validation Analyst to support validation processes for their Quality Management System and SAP implementation. The position requires a Bachelor's degree in Life Sciences or a related field and 3+ years of experience in validation within a GxP environment. This role involves authoring validation protocols and ensuring compliance with regulations.

This is an on-site position located in Piscataway, NJ, or Chicago, IL, providing a rate of $65–$75/hour without overtime eligibility.

Qualifications

• 3+ years relevant experience in validation support.
• Exposure to CSV activities in a GxP-regulated environment.
• Understanding of regulations like 21 CFR Part 11.

Responsibilities

• Support validation of MasterControl QMS.
• Assist in SAP implementation and validation activities.
• Contribute to risk assessments and audit readiness.

Skills

Validation Protocols Authoring

GxP Environment Exposure

SAP Familiarity

Data Integrity Principles

Education

Bachelor's degree in Life Sciences or related field

Master's degree in Life Sciences or related field

Tools

MasterControl QMS

SAP Modules (QM, MM, PP)

Caliber LIMS

Job 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

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.