CIP/SIP CQV Validation Engineer — Biotech Pharma

Veg Group; Puerto Rico; On-site; USD 80,000 - 100,000; Full time

Job summary

A leading services supplier in the biotechnology sector is seeking a Validation Specialist to plan, coordinate, and execute Commissioning, Qualification, and Validation (CQV) activities within a biotech manufacturing environment. Candidates should possess a bachelor's degree in engineering and have 7-10 years of relevant experience. The role demands strong knowledge of cleaning validation principles, automation integration, and familiarity with FDA/EMA guidelines. Bilingual proficiency in English and Spanish is required. Join a dynamic team to shape the future of healthcare and technology.

Qualifications

• Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.
• Expertise in ASTM E2500, ISPE Baseline Guides, and FDA/EMA guidelines.
• Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems.

Responsibilities

• Plan and coordinate CQV activities related to CIP and SIP systems.
• Generate and review URS, FAT/SAT, IOQ, and PQ documentation.
• Collaborate with Process Engineers and QA to ensure successful CIP/SIP operations.

Skills

CQV documentation execution

Bilingual (English / Spanish)

Cleaning validation principles

Strong knowledge of automation integration

Education

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

Tools

DeltaV

SCADA

PLC systems

Job description

A leading services supplier in the biotechnology sector is seeking a Validation Specialist to plan, coordinate, and execute Commissioning, Qualification, and Validation (CQV) activities within a biotech manufacturing environment. Candidates should possess a bachelor's degree in engineering and have 7-10 years of relevant experience. The role demands strong knowledge of cleaning validation principles, automation integration, and familiarity with FDA/EMA guidelines. Bilingual proficiency in English and Spanish is required. Join a dynamic team to shape the future of healthcare and technology.