MES Engineer

{
  "content_hash": "4e3fc2a1ea2daf083da34458c934f0ca5a277e47039ec87189aac4366278bb7b",
  "source_hash": "b671054e2dbfbd530acfbaa9eb7540ee9eaf158258dd66c6aa604514d87bcd92",
  "last_changed_at": "2026-05-31T17:37:47.446Z",
  "active_status": "active"
}

{
  "language": "en",
  "location": {
    "raw": "Morrisville, NC, United States",
    "city": "Morrisville",
    "region": "NC",
    "country": "United States",
    "is_remote": false,
    "confidence": 0.8
  },
  "salary_max": null,
  "salary_min": null,
  "inferred_at": "2026-06-06T20:08:56.272Z",
  "launch_scope": {
    "reason": "english_us_canada",
    "included": true,
    "language": "en",
    "location": {
      "raw": "Morrisville, NC, United States",
      "city": "Morrisville",
      "region": "NC",
      "country": "United States",
      "is_remote": false,
      "confidence": 0.8
    },
    "countries": [
      "United States"
    ]
  },
  "remote_policy": null,
  "salary_period": null,
  "workplace_type": null,
  "salary_currency": null
}

{}

{
  "id": "744000084947055",
  "ref": "https://api.smartrecruiters.com/v1/companies/validationengineeringgroup/postings/744000084947055",
  "name": "MES Engineer",
  "uuid": "c69f20de-ee5f-46d5-b65f-e66c41a578c5",
  "detail": {
    "id": "744000084947055",
    "name": "MES Engineer",
    "uuid": "c69f20de-ee5f-46d5-b65f-e66c41a578c5",
    "jobAd": {
      "sections": {
        "jobDescription": {
          "text": "<p><strong>Senior Computer System Validation (CSV) Specialist&#xa0;</strong>- with expertise in&#xa0;<strong>Manufacturing Execution Systems (MES), specifically Syncade</strong>, to support a biologics manufacturing facility. The role will be responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. The candidate will work closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle.</p><p><strong>Key Responsibilities</strong></p><ul><li><strong>Lead and execute CSV activities for MES (Syncade) in a biologics GMP environment.</strong></li><li>Develop and maintain validation documentation including Validation Plans, User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, IQ/OQ/PQ protocols, and summary reports.</li><li><strong>Partner with Manufacturing and Quality to ensure MES recipes, workflows, and master batch records are validated and compliant.</strong></li><li>Perform impact assessments and change control for system upgrades, patches, and enhancements.</li><li>Ensure alignment of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other applicable regulations.</li><li>Collaborate with IT and Engineering teams for system integration (e.g., LIMS, ERP/SAP, DeltaV, PI Historian).</li><li>Provide audit support during regulatory inspections (FDA, EMA, MHRA, etc.) and customer audits.</li><li>Mentor junior validation engineers and support knowledge transfer on CSV best practices.</li><li>Contribute to continuous improvement of MES validation strategies, procedures, and templates.</li></ul>",
          "title": "Job Description"
        },
        "qualifications": {
          "text": "<p><strong>Qualifications</strong></p><ul><li>Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field. Advanced degree preferred.</li><li><strong>7–10+ years of experience in Computer System Validation within GMP-regulated biologics/pharmaceutical manufacturing.</strong></li><li>Hands-on expertise with MES Syncade validation and configuration (recipes, workflows, batch records).</li><li>Strong knowledge of regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q7, GAMP 5.</li><li>Experience in biologics manufacturing processes (cell culture, purification, fill/finish).</li><li>Familiarity with integration points (DCS/DeltaV, LIMS, ERP/SAP, data historians).</li><li>Excellent technical writing and documentation skills.</li><li>Strong communication, leadership, and problem-solving abilities.</li></ul><p><strong>Preferred Skills</strong></p><ul><li>Experience in large-scale biotech/biologics start-up or tech transfer projects.</li><li>Knowledge of data integrity principles and ALCOA+ requirements.</li><li><strong>Exposure to quality management systems (TrackWise, Veeva, ValGenesis, Kneat).</strong></li><li>Understanding of 21st Century Cures Act and CSA (Computer Software Assurance) approaches.</li></ul>",
          "title": "Qualifications"
        },
        "companyDescription": {
          "text": "<p><em><strong>Validation &amp; Engineering Group, Inc.&#xa0;</strong></em>(V&amp;EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.</p><p>&#xa0;</p>",
          "title": "Company Description"
        },
        "additionalInformation": {
          "text": "<p>All your information will be kept confidential according to EEO guidelines.</p>",
          "title": "Additional Information"
        }
      }
    },
    "jobId": "d6716b08-ee21-40df-a649-fcc41be72b3b",
    "active": true,
    "company": {
      "name": "Validation & Engineering Group",
      "identifier": "ValidationEngineeringGroup"
    },
    "creator": {
      "name": "",
      "avatarUrl": ""
    },
    "jobAdId": "cc47311d-264e-41f1-9daa-24dac6848700",
    "applyUrl": "https://jobs.smartrecruiters.com/ValidationEngineeringGroup/744000084947055-mes-engineer?oga=true",
    "function": {
      "id": "engineering",
      "label": "Engineering"
    },
    "industry": {
      "id": "pharmaceuticals",
      "label": "Pharmaceuticals"
    },
    "language": {
      "code": "en",
      "label": "English",
      "labelNative": "English (US)"
    },
    "location": {
      "city": "Morrisville",
      "hybrid": false,
      "region": "NC",
      "remote": false,
      "address": "Morrisville Carpenter Road",
      "country": "us",
      "latitude": "35.81843",
      "longitude": "-78.8388426",
      "fullLocation": "Morrisville, NC, United States"
    },
    "refNumber": "REF670Q",
    "postingUrl": "https://jobs.smartrecruiters.com/ValidationEngineeringGroup/744000084947055-mes-engineer",
    "visibility": "PUBLIC",
    "customField": [
      {
        "fieldId": "COUNTRY",
        "valueId": "us",
        "fieldLabel": "Country/Region",
        "valueLabel": "United States"
      },
      {
        "fieldId": "58b7e508e4b0885c92cd9a37",
        "valueId": "default",
        "fieldLabel": "Brands",
        "valueLabel": "Validation & Engineering Group"
      }
    ],
    "referralUrl": "https://jobs.smartrecruiters.com/external-referrals/company/ValidationEngineeringGroup/publication/c69f20de-ee5f-46d5-b65f-e66c41a578c5?dcr_ci=ValidationEngineeringGroup",
    "defaultJobAd": true,
    "releasedDate": "2025-09-30T17:44:20.285Z",
    "experienceLevel": {
      "id": "mid_senior_level",
      "label": "Mid-Senior Level"
    },
    "typeOfEmployment": {
      "id": "permanent",
      "label": "Full-time"
    }
  },
  "company": {
    "name": "Validation & Engineering Group",
    "identifier": "ValidationEngineeringGroup"
  },
  "jobAdId": "cc47311d-264e-41f1-9daa-24dac6848700",
  "function": {
    "id": "engineering",
    "label": "Engineering"
  },
  "industry": {
    "id": "pharmaceuticals",
    "label": "Pharmaceuticals"
  },
  "language": {
    "code": "en",
    "label": "English",
    "labelNative": "English (US)"
  },
  "location": {
    "city": "Morrisville",
    "hybrid": false,
    "region": "NC",
    "remote": false,
    "address": "Morrisville Carpenter Road",
    "country": "us",
    "latitude": "35.81843",
    "longitude": "-78.8388426",
    "fullLocation": "Morrisville, NC, United States"
  },
  "refNumber": "REF670Q",
  "department": {},
  "visibility": "PUBLIC",
  "customField": [
    {
      "fieldId": "COUNTRY",
      "valueId": "us",
      "fieldLabel": "Country/Region",
      "valueLabel": "United States"
    },
    {
      "fieldId": "58b7e508e4b0885c92cd9a37",
      "valueId": "default",
      "fieldLabel": "Brands",
      "valueLabel": "Validation & Engineering Group"
    }
  ],
  "defaultJobAd": true,
  "releasedDate": "2025-09-30T17:44:20.285Z",
  "detail_errors": [],
  "experienceLevel": {
    "id": "mid_senior_level",
    "label": "Mid-Senior Level"
  },
  "typeOfEmployment": {
    "id": "permanent",
    "label": "Full-time"
  }
}