Validation Specialist — Equipment 

Location: Barceloneta, Puerto Rico (On-site)
Shift: Day (7:00 a.m. – 5:00 p.m.)
Start: ASAP

Role Overview

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.

Key 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.

Minimum Qualifications

• 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).

Preferred

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

Onboarding

• One day of on-site training; computer/system access to follow.