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Validation Engineer

3 months ago

Bryan, United States Premier Life Sciences LLC Full time

Job Title: Validation Engineer - Pharma

Location: College Station, Texas

Duration: 6+ Months


**No C2C**


Summary: Responsible for drafting and executing validation protocols for Facilities, Utilities, Systems, and Equipment (FUSE) under general supervision. This role includes preparing and completing validation final reports for these systems.

Essential Functions:

  • Generate, obtain approval, and execute validation deliverables, including Validation Plans, System Impact Assessments, User Requirements Specifications, Risk Assessments, Installation/Operational Qualifications, Performance Qualifications, and Validation Final Reports, ensuring compliance with regulatory and procedural requirements.
  • Plan and organize validation activities among cross-functional groups, with guidance from senior validation engineers or the validation manager, and provide status updates on validation activities.
  • Independently draft protocols, execute validation tasks, analyze data, and write reports with minimal supervision.
  • Review FUSE System Delivery Life Cycle (SDLC) deliverables, provide feedback, and ensure compliance with Standard Operating Procedures (SOPs).
  • Review and update SOPs, forms, templates, documentation, and files.
  • Perform duties in a compliant, ethical manner in line with all applicable laws, regulations, and industry codes.
  • Additional duties as assigned.


Required Skills & Abilities:

  • Strong knowledge of engineering principles.
  • Expertise in FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, and Temperature-Controlled Units (2-8°C, -80°C, LN2 Freezers, Incubators).
  • Proficient in ISPE Baseline 5, Vol. 2 – Commissioning and Qualification, and FDA industry regulations.
  • Excellent written and oral communication skills.
  • Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint).
  • Ability to work under general guidance from senior validation engineers or the validation manager.