Validation Specialist — Equipment

Weil GroupBarceloneta, PR
2dOnsite

About The Position

Execute and support validation for new and existing equipment , partnering closely with Construction, Utilities, Operations, and Quality. You will prepare/execute protocols, assess project impacts, and ensure inspection-ready documentation and safe, compliant start-ups..

Requirements

  • Bachelor’s degree preferred (Engineering, Science, or related) or equivalent experience.
  • Validation experience in pharma or highly regulated manufacturing; cleanroom familiarity.
  • Strong collaboration with PM/Field teams; excellent written and verbal communication.
  • Proficiency with MS Office and basic schedule/document tools; day-shift availability (7–5).

Nice To Haves

  • Exposure to commissioning/qualification interfaces (e.g., IQ/OQ/PQ), risk tools (FMEA/pFMEA), and data integrity practices.

Responsibilities

  • Plan and execute equipment validation activities aligned to construction/utilities work in cleanrooms.
  • Coordinate with area owners on documentation, materials, and training; maintain change and deviation records.
  • Generate and maintain validation packages (protocols, reports, traceability, risk assessments) and supporting logs.
  • Support readiness for start-up, walk-downs, and handover; address gaps to meet regulatory expectations.
  • Adhere to EHS/Security , cGMP , and site procedures; provide precise status and metrics.
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