Equipment Validation Specialist III

SGS_JOB_1072

Scientific
 New Hampshire
Equipment Validation
GMP Compliance
Validation Protocols
Quality Systems
Biopharmaceutical Manufacturing
Validation Maintenance
SOP Reviews
TrackWise
Data Integrity
Technical Support
Troubleshooting

Contract - 09 months + (Possibilities of Extension)

The Equipment Validation Specialist is responsible for ensuring that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. This role provides scientifically sound, documented evidence to Operations, Quality Assurance, and regulatory bodies, supporting a quality, compliant manufacturing environment.

Job Responsibilities:

  • Perform Equipment Validation activities, including validation maintenance, quality systems review, and requalification, ensuring GMP equipment remains in a validated state.
  • Program, organize, and maintain validation equipment and supplies, including dataloggers and probes.
  • Demonstrate understanding of biopharmaceutical manufacturing equipment and validation procedures (Installation Verification, Steam-In-Place, Autoclaves, Clean Utilities, Temperature Mapping, Shipping Validation).
  • Develop validation protocols based on plans and engineering documents.
  • Provide basic technical support in reviewing and approving SOPs, protocols, change controls, deviations, and CAPAs.
  • Perform assigned Quality Systems activities within Document Management System (DMS), Laboratory Information Management System (LIMS), and TrackWise (Change Control, Deviation, CAPA).
  • Perform other duties as assigned.

Skills:

  • Good working knowledge of Validation deliverables and Data Integrity principles.
  • Experience with Quality Systems, including deviations, change controls, CAPAs, OTNs, and TrackWise.
  • Knowledge in process, equipment, cleaning, and computer system validations, with the ability to review and approve protocols and reports.
  • Sound decision-making and problem-solving abilities.
  • Ability to collaborate across departments and with customers.
  • Demonstrates role-model behaviors for GMP and safety standards.
  • Strong written and verbal communication skills.
  • Proficiency in MS Project, Word, Excel, PowerPoint.

Education/Experience:

  • Education: High School Diploma or Equivalent; Bachelor of Science in a science-related discipline (preferred).
  • Experience: Manufacturing, QC, or Validation (Entry-Level 0-4 years).

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