Computer System Validation (CSV) Engineer

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    "description_html": "<p><br></p><p><strong>Position Type:</strong> Full-time Employee (FTE)</p><p><strong>Location:</strong> Piscataway, NJ (onsite - physical presence required)</p><p><strong>Reports To:</strong> Sr. Director of IT</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 an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.</p><p><br></p><p><u><strong>Essential Duties &amp; Responsibilities</strong></u></p><ul><li>Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems</li><li>Support CSV activities across lab instruments (HPLC, GC, spectrophotometers, balances, etc.), engineering and manufacturing equipment, and enterprise systems including Caliber LIMS, SAP, and BMRAM</li><li>Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review</li><li>Execute risk assessments and data integrity assessments aligned with ALCOA+ principles</li><li>Support audits, inspections, CAPA investigations, and deviations related to computerized systems</li><li>Collaborating with senior validation leads and SMEs to drive consistent practices across sites</li></ul>",
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      "description": "<p>Description</p><p><br/></p><p><strong>Position Type:</strong> Full-time Employee (FTE)</p><p><strong>Location:</strong> Piscataway, NJ (onsite - physical presence required)</p><p><strong>Reports To:</strong> Sr. Director of IT</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 an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.</p><p><br/></p><p><u><strong>Essential Duties & Responsibilities</strong></u></p><ul><li>Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems</li><li>Support CSV activities across lab instruments (HPLC, GC, spectrophotometers, balances, etc.), engineering and manufacturing equipment, and enterprise systems including Caliber LIMS, SAP, and BMRAM</li><li>Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review</li><li>Execute risk assessments and data integrity assessments aligned with ALCOA+ principles</li><li>Support audits, inspections, CAPA investigations, and deviations related to computerized systems</li><li>Collaborating with senior validation leads and SMEs to drive consistent practices across sites</li></ul><p>Requirements</p><p><u><strong>Position Requirements and Qualifications</strong></u></p><ul><li>Bachelor's degree in Life Sciences, Engineering, or IT; OR equivalent laboratory experience in a life sciences environment</li><li>Minimum 5 years of CSV experience in a GxP-regulated environment</li><li>Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance</li><li>Hands-on experience authoring and executing IQ/OQ/PQ protocols</li><li>Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)</li></ul><p><strong>Experience:  </strong></p><ul><li>Minimum 5 years of CSV experience in a GxP-regulated environment</li><li>Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance</li><li>Hands-on experience authoring and executing IQ/OQ/PQ protocols</li><li>Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)</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>Experience with BMRAM or equivalent CMMS/calibration systems</li><li>Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams</li></ul><p><u><strong>Work Environment & Physical Demands:</strong></u></p><ul><li>This is an on-site position</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>",
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    "requirements_html": "<p><u><strong>Position Requirements and Qualifications</strong></u></p><ul><li>Bachelor's degree in Life Sciences, Engineering, or IT; OR equivalent laboratory experience in a life sciences environment</li><li>Minimum 5 years of CSV experience in a GxP-regulated environment</li><li>Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance</li><li>Hands-on experience authoring and executing IQ/OQ/PQ protocols</li><li>Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)</li></ul><p><strong>Experience: &nbsp;</strong></p><ul><li>Minimum 5 years of CSV experience in a GxP-regulated environment</li><li>Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance</li><li>Hands-on experience authoring and executing IQ/OQ/PQ protocols</li><li>Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)</li></ul><p><strong>Specialized Knowledge and Skills:&nbsp;</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>Experience with BMRAM or equivalent CMMS/calibration systems</li><li>Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams</li></ul><p><u><strong>Work Environment &amp; Physical Demands:</strong></u></p><ul><li>This is an on-site position</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>",
    "requirements_text": "Position Requirements and Qualifications\n Bachelor's degree in Life Sciences, Engineering, or IT; OR equivalent laboratory experience in a life sciences environment\n Minimum 5 years of CSV experience in a GxP-regulated environment\n Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance\n Hands-on experience authoring and executing IQ/OQ/PQ protocols\n Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)\n Experience:\n Minimum 5 years of CSV experience in a GxP-regulated environment\n Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance\n Hands-on experience authoring and executing IQ/OQ/PQ protocols\n Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)\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 Experience with BMRAM or equivalent CMMS/calibration systems\n Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams\n Work Environment & Physical Demands:\n This is an on-site position\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."
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