Validation Specialist

QRC Group, LLC • Caguas, PR

16h • Onsite

About The Position

Validation Specialist to support validation activities within a regulated Medical Devices manufacturing environment. The ideal candidate will have strong knowledge of the Validation Life Cycle and hands-on experience executing validation deliverables in compliance with FDA and global regulatory requirements.

Requirements

• Bachelor’s Degree in Engineering, Life Sciences, or related field.
• 3–5+ years of experience in validation within the Medical Devices or Pharmaceutical industry.
• Strong understanding of the Validation Life Cycle (VLC).
• Experience with Equipment and process validation
• Protocol development and execution (IQ/OQ/PQ)
• Risk management tools (FMEA, risk analysis)
• Working knowledge of FDA regulations, and cGMP standards.
• Excellent technical writing and documentation skills.
• Bilingual (English/Spanish).

Responsibilities

• Execute and support validation protocols and reports including IQ, OQ, PQ for equipment, utilities, processes, and/or computer systems.
• Ensure all validation activities comply with applicable regulations and site quality standards.
• Lead and/or support the full Validation Life Cycle (planning, risk assessment, execution, and closure).
• Develop and review validation documentation including Validation Plans, URS, FRS, RTM, protocols, and summary reports.
• Participate in risk assessments (e.g., FMEA) to determine validation approach and scope.
• Collaborate with cross-functional teams (Engineering, Quality, Manufacturing, Regulatory Affairs) to ensure project timelines are met.
• Support change control activities and assess validation impact for changes.
• Troubleshoot validation issues and implement corrective actions as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level