• 
  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.

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).