CIP/SIP CQV Validation Engineer — Biotech Pharma

Veg Group; Humacao (PR); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading engineering firm is seeking a Validation Specialist involved in Commissioning, Qualification, and Validation (CQV) activities for Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems in a biotech manufacturing context. The ideal candidate will possess a degree in Chemical, Mechanical, or Biochemical Engineering and have 7-10 years of relevant experience. Proficiency in both English and Spanish is essential. The company prides itself on offering an empowering work environment where people can thrive.

Qualifications

• Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing.
• Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.
• Strong knowledge of FDA/EMA guidelines.

Responsibilities

• Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.
• Execute IOQ and PQ protocols for CIP/SIP systems.
• Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.

Skills

Cleaning validation

Sterilization principles

Automation integration

CQV documentation

Bilingual (English / Spanish)

Education

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

Tools

DeltaV

SCADA

PLC systems

Kneat

ValGenesis

Job description

A leading engineering firm is seeking a Validation Specialist involved in Commissioning, Qualification, and Validation (CQV) activities for Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems in a biotech manufacturing context. The ideal candidate will possess a degree in Chemical, Mechanical, or Biochemical Engineering and have 7-10 years of relevant experience. Proficiency in both English and Spanish is essential. The company prides itself on offering an empowering work environment where people can thrive.