CIP/SIP CQV Validation Engineer — Biotech Pharma

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

Job summary

A leading engineering group in Juana Díaz, Puerto Rico is seeking a Validation Specialist responsible for planning and executing CQV activities related to Cleaning-In-Place systems. The ideal candidate will have 7–10 years of experience in biotech or pharmaceutical manufacturing, a bachelor's degree, and strong expertise in cleaning validation and automation. Bilingual proficiency in English and Spanish is required. Join a purpose-driven team to make a meaningful impact in healthcare.

Qualifications

• Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.
• Experience generating and executing documentation for CQV activities.
• Familiarity with ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.

Responsibilities

• Plan, coordinate, and execute CQV activities related to Cleaning-In-Place systems.
• Generate and review URS, FAT/SAT, IOQ, and PQ documentation.
• Support operations during process validation batches.

Skills

Cleaning validation

Sterilization principles

Automation integration

Bilingual (English/Spanish)

Data integrity

Education

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

Tools

DeltaV

SCADA

PLC systems

Kneat

ValGenesis

Job description

A leading engineering group in Juana Díaz, Puerto Rico is seeking a Validation Specialist responsible for planning and executing CQV activities related to Cleaning-In-Place systems. The ideal candidate will have 7–10 years of experience in biotech or pharmaceutical manufacturing, a bachelor's degree, and strong expertise in cleaning validation and automation. Bilingual proficiency in English and Spanish is required. Join a purpose-driven team to make a meaningful impact in healthcare.