Lead CIP Validation Engineer – Biotech & GMP

Pinnaql, Inc.; Juana Díaz (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a highly skilled Validation Specialist for CIP/SIP systems in a biotech manufacturing environment. You will plan, coordinate, and execute CQV activities to ensure systems meet GMP and regulatory standards.

Responsibilities include IOQ/PQ testing, documentation, data integrity, and cross-functional collaboration with QA, Process, Automation, and Manufacturing, with bilingual English/Spanish communication. Extended hours and weekend work may be required.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).
• 7–10 years CQV experience in biotech or pharmaceutical manufacturing.
• Experience generating and executing documentation for CQV activities.
• Strong knowledge of cleaning validation, sterilization principles, and automation integration.
• Familiarity with ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.
• Fully bilingual English/Spanish with excellent oral skills.

Responsibilities

• Plan, coordinate, and execute CQV activities for CIP/SIP systems.
• Review vendor FAT/SAT and oversee IOQ/PQ testing.
• Prepare CQV documentation and ensure compliance with ASTM E2500 and GAMP 5.
• Collaborate with Automation, Process, QA Validation, and Manufacturing.

Skills

CQV experience

Documentation

GMP knowledge

Bilingual EN/ES

Cross-functional collaboration

Education

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

Tools

DeltaV

SCADA

PLC systems

Job description

Validation & Engineering Group, Inc. seeks a highly skilled Validation Specialist for CIP/SIP systems in a biotech manufacturing environment. You will plan, coordinate, and execute CQV activities to ensure systems meet GMP and regulatory standards.

Responsibilities include IOQ/PQ testing, documentation, data integrity, and cross-functional collaboration with QA, Process, Automation, and Manufacturing, with bilingual English/Spanish communication. Extended hours and weekend work may be required.