QMS & SAP Validation Analyst (Contract)

{
  "content_hash": "6f7b9ec6e408e311e4afc8afef6a6b4095ffee5094fdcea2cd9cf7b71289f507",
  "source_hash": "157a8afc7d4d129aca4a4c680cae9bb2bfd8f9a7642614e66e12d69a7750580e",
  "last_changed_at": "2026-06-02T07:39:24.165Z",
  "active_status": "active"
}

{
  "language": "en",
  "location": {
    "raw": "Kashiv BioSciences - Piscataway",
    "city": "Piscataway",
    "region": "NJ",
    "country": "United States",
    "is_remote": false,
    "confidence": 0.8
  },
  "salary_max": null,
  "salary_min": null,
  "inferred_at": "2026-06-06T13:39:40.227Z",
  "launch_scope": {
    "reason": "paylocity_production_catalog",
    "included": true,
    "location": {
      "raw": "Kashiv BioSciences - Piscataway",
      "city": "Piscataway",
      "region": "NJ",
      "country": "United States",
      "is_remote": false,
      "confidence": 0.8
    },
    "countries": [
      "United States"
    ]
  },
  "remote_policy": null,
  "salary_period": null,
  "workplace_type": "on_site",
  "salary_currency": null
}

{}

{
  "detail": {
    "url": "https://recruiting.paylocity.com/recruiting/jobs/Details/4217099/Kashiv-Biosciences-LLC/QMS-and-SAP-Validation-Analyst-Contract",
    "job_type": "Contract",
    "pageData": {
      "jobTitle": "QMS & SAP Validation Analyst (Contract)",
      "moduleName": "Kashiv Biosciences LLC",
      "showSocialWidget": true
    },
    "apply_path": "/Recruiting/jobs/Apply/4217099",
    "html_title": "Kashiv Biosciences LLC - QMS & SAP Validation Analyst (Contract)",
    "description_html": "<p><br></p><p><strong>Position Type:</strong> Contractor / Consultant – FTC (6-9 Months with possible extension)</p><p><strong>Location:</strong> Piscataway, NJ (onsite - physical presence required) <strong>– OR –</strong> Chicago, IL (onsite - physical presence required)</p><p><strong>Reports To:</strong> Sr. Director of IT</p><p><strong>Rate:</strong> $65–$75/hour, not overtime eligible</p><p><strong>Work Authorization:</strong> Must be authorized to work in the U.S. without sponsorship, now or in the future</p><p><br></p><p><u><strong>Position Summary</strong></u></p><p><br></p><p>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.</p><p><br></p><p><u><strong>Essential Duties &amp; Responsibilities</strong></u></p><ul><li>Support validation of MasterControl QMS - authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports</li><li>Support &nbsp;SAP implementation and validation activities across QM, MM, and PP modules, including test script authoring and execution under senior oversight</li><li>Contribute to risk assessments, data integrity assessments, and change control documentation</li><li>Liaise with QA, IT, business process owners, and external SAP implementation partners</li><li>Support periodic review and maintenance of validated state for assigned systems</li><li>Assist in audit and inspection readiness for MasterControl and SAP</li></ul>",
    "jsonld_jobposting": {
      "@type": "JobPosting",
      "title": "QMS & SAP Validation Analyst (Contract)",
      "@context": "https://schema.org",
      "datePosted": "2026-06-02T00:26:31-05:00",
      "description": "<p>Description</p><p><br/></p><p><strong>Position Type:</strong> Contractor / Consultant – FTC (6-9 Months with possible extension)</p><p><strong>Location:</strong> Piscataway, NJ (onsite - physical presence required) <strong>– OR –</strong> Chicago, IL (onsite - physical presence required)</p><p><strong>Reports To:</strong> Sr. Director of IT</p><p><strong>Rate:</strong> $65–$75/hour, not overtime eligible</p><p><strong>Work Authorization:</strong> Must be authorized to work in the U.S. without sponsorship, now or in the future</p><p><br/></p><p><u><strong>Position Summary</strong></u></p><p><br/></p><p>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.</p><p><br/></p><p><u><strong>Essential Duties & Responsibilities</strong></u></p><ul><li>Support validation of MasterControl QMS - authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports</li><li>Support  SAP implementation and validation activities across QM, MM, and PP modules, including test script authoring and execution under senior oversight</li><li>Contribute to risk assessments, data integrity assessments, and change control documentation</li><li>Liaise with QA, IT, business process owners, and external SAP implementation partners</li><li>Support periodic review and maintenance of validated state for assigned systems</li><li>Assist in audit and inspection readiness for MasterControl and SAP</li></ul><p>Requirements</p><p> <u><strong>Position Requirements and Qualifications</strong></u></p><ul><li>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</li><li>Prior exposure to CSV activities in a GxP-regulated environment</li><li>Working understanding of 21 CFR Part 11, EU Annex 11, and EMA guidance</li><li>Experience authoring or executing validation protocols</li></ul><p><strong>Experience:  </strong></p><ul><li>Exposure to MasterControl QMS (validation, administration, or end-user)</li><li>Exposure to SAP (any module, ideally QM, MM, or PP) in a GxP environment</li><li>Familiarity with GAMP 5 principles</li><li>Experience with ALCOA+ data integrity principles</li><li>Prior experience supporting enterprise system implementations in pharma, biotech, or medical device</li></ul><p><strong>Specialized Knowledge and Skills:</strong> · </p><ul><li>Familiarity with GAMP 5 principles and risk-based validation</li><li>Exposure to Caliber LIMS</li><li>Exposure to SAP (QM, MM, PP) in a GxP context</li><li>Prior experience and acting as a liaison across IT, Quality, Lab, and ERP (SAP Preferred) and related systems.</li></ul><p><u><strong>Work Environment & Physical Demands:</strong></u>· </p><ul><li>This is an on-site position at our Piscataway, NJ location – OR – Chicago, IL location· </li><li>Must be able to work extended hours or weekend hours, as may be required.</li></ul><p><u>Noise:</u>· </p><ul><li>No extraordinary noise levels.</li></ul><p><u>Standing/Lifting:</u>· </p><ul><li>Very unlikely, but can be able to lift at least 20 lbs.</li></ul><p><u>Visual:</u>· </p><ul><li>No extraordinary requirements.</li></ul><p><u>Stress:</u>· </p><ul><li>High-paced demanding environment to meet ambitious project goals.</li></ul><p><u>Travel:</u>· </p><ul><li>Moderate domestic travel may be required. </li></ul>",
      "jobLocation": {
        "@type": "Place",
        "address": {
          "@type": "PostalAddress",
          "postalCode": "08854",
          "addressRegion": "NJ",
          "streetAddress": "20 New England Ave",
          "addressCountry": "US",
          "addressLocality": "Piscataway"
        }
      },
      "hiringOrganization": {
        "logo": "https://recruiting.paylocity.com/recruiting/jobs/GetLogoFile?moduleId=20186",
        "name": "Kashiv BioSciences, LLC",
        "@type": "Organization"
      }
    },
    "requirements_html": "<p>&nbsp;<u><strong>Position Requirements and Qualifications</strong></u></p><ul><li>Bachelor's degree in Life Sciences, Engineering, IT, or a lab-based role in life &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;sciences with 3+ years of relevant experience; OR Master's degree with 1–2 years of relevant experience</li><li>Prior exposure to CSV activities in a GxP-regulated environment</li><li>Working understanding of 21 CFR Part 11, EU Annex 11, and EMA guidance</li><li>Experience authoring or executing validation protocols</li></ul><p><strong>Experience: &nbsp;</strong></p><ul><li>Exposure to MasterControl QMS (validation, administration, or end-user)</li><li>Exposure to SAP (any module, ideally QM, MM, or PP) in a GxP environment</li><li>Familiarity with GAMP 5 principles</li><li>Experience with ALCOA+ data integrity principles</li><li>Prior experience supporting enterprise system implementations in pharma, biotech, or medical device</li></ul><p><strong>Specialized Knowledge and Skills:</strong> ·&nbsp;</p><ul><li>Familiarity with GAMP 5 principles and risk-based validation</li><li>Exposure to Caliber LIMS</li><li>Exposure to SAP (QM, MM, PP) in a GxP context</li><li>Prior experience and acting as a liaison across IT, Quality, Lab, and ERP (SAP Preferred) and related systems.</li></ul><p><u><strong>Work Environment &amp; Physical Demands:</strong></u>·&nbsp;</p><ul><li>This is an on-site position at our Piscataway, NJ location – OR – Chicago, IL location·&nbsp;</li><li>Must be able to work extended hours or weekend hours, as may be required.</li></ul><p><u>Noise:</u>·&nbsp;</p><ul><li>No extraordinary noise levels.</li></ul><p><u>Standing/Lifting:</u>·&nbsp;</p><ul><li>Very unlikely, but can be able to lift at least 20 lbs.</li></ul><p><u>Visual:</u>·&nbsp;</p><ul><li>No extraordinary requirements.</li></ul><p><u>Stress:</u>·&nbsp;</p><ul><li>High-paced demanding environment to meet ambitious project goals.</li></ul><p><u>Travel:</u>·&nbsp;</p><ul><li>Moderate domestic travel may be required.&nbsp;</li></ul>",
    "requirements_text": "Position Requirements and Qualifications\n 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\n Prior exposure to CSV activities in a GxP-regulated environment\n Working understanding of 21 CFR Part 11, EU Annex 11, and EMA guidance\n Experience authoring or executing validation protocols\n Experience:\n Exposure to MasterControl QMS (validation, administration, or end-user)\n Exposure to SAP (any module, ideally QM, MM, or PP) in a GxP environment\n Familiarity with GAMP 5 principles\n Experience with ALCOA+ data integrity principles\n Prior experience supporting enterprise system implementations in pharma, biotech, or medical device\n Specialized Knowledge and Skills: ·\n Familiarity with GAMP 5 principles and risk-based validation\n Exposure to Caliber LIMS\n Exposure to SAP (QM, MM, PP) in a GxP context\n Prior experience and acting as a liaison across IT, Quality, Lab, and ERP (SAP Preferred) and related systems.\n Work Environment & Physical Demands: ·\n This is an on-site position at our Piscataway, NJ location – OR – Chicago, IL location·\n Must be able to work extended hours or weekend hours, as may be required.\n Noise: ·\n No extraordinary noise levels.\n Standing/Lifting: ·\n Very unlikely, but can be able to lift at least 20 lbs.\n Visual: ·\n No extraordinary requirements.\n Stress: ·\n High-paced demanding environment to meet ambitious project goals.\n Travel: ·\n Moderate domestic travel may be required."
  },
  "list_job": {
    "JobId": 4217099,
    "IsRemote": false,
    "JobTitle": "QMS & SAP Validation Analyst (Contract)",
    "IsInternal": false,
    "Description": "",
    "JobLocation": {
      "Zip": "08854",
      "City": "Piscataway",
      "Name": "Kashiv BioSciences - Piscataway",
      "Metro": null,
      "State": "NJ",
      "County": null,
      "Address": "20 New England Ave",
      "Country": "USA",
      "Address2": null,
      "ModuleId": 20186,
      "LocationId": 4142236,
      "SmartyAddressId": "e5f1eea0-5e59-4293-8553-9c1f3c4de5b4"
    },
    "LocationName": "Kashiv BioSciences - Piscataway",
    "PublishedDate": "2026-06-01T19:26:25-05:00",
    "HiringDepartment": "Information Technology",
    "IndeedRemoteType": 2,
    "ShouldDisplayLocation": true
  },
  "detail_errors": []
}