Senior CIP/SIP CQV Validation Engineer

Veg Group; Carolina (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading engineering services provider in Puerto Rico seeks a Validation Specialist to manage commissioning and qualification activities for Cleaning-In-Place systems in biotech manufacturing. This role involves ensuring compliance with GMP, FDA, and ASTM standards and requires a Bachelor's degree in Engineering, along with 7–10 years of experience in CQV activities. The ideal candidate is bilingual in English and Spanish and has strong expertise in cleaning validation processes. Join a supportive team dedicated to shaping healthcare technology.

Qualifications

• Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.
• Strong knowledge of cleaning validation and automation integration.
• Experience executing FAT/SAT, IOQ, and PQ activities.

Responsibilities

• Plan, coordinate, and execute CQV activities related to Cleaning-In-Place.
• Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.
• Generate and review compliance documentation in line with industry standards.

Skills

Cleaning validation

Sterilization principles

Documentation generation

Bilingual (English / Spanish)

Automation integration

Education

Bachelor's degree in Chemical, Mechanical, or Biochemical Engineering

Tools

DeltaV

SCADA

PLC systems

Kneat

ValGenesis

Job description

A leading engineering services provider in Puerto Rico seeks a Validation Specialist to manage commissioning and qualification activities for Cleaning-In-Place systems in biotech manufacturing. This role involves ensuring compliance with GMP, FDA, and ASTM standards and requires a Bachelor's degree in Engineering, along with 7–10 years of experience in CQV activities. The ideal candidate is bilingual in English and Spanish and has strong expertise in cleaning validation processes. Join a supportive team dedicated to shaping healthcare technology.