CIP/SIP Validation Engineer (Biotech/Pharma)

Pinnaql, Inc.; Juncos (PR); On-site; USD 110,000 - 150,000; Full time

Job summary

Validation & Engineering Group, Inc. (a Pinnaql company) seeks a Validation Specialist for CIP/SIP in a biotech manufacturing setting.

You will plan, coordinate, and execute CQV activities, ensuring GMP, FDA/EMA compliance and data integrity. Responsibilities include reviewing vendor FAT/SAT, IOQ/PQ execution, utility qualification, documentation per ASTM E2500 and GAMP 5, and cross-functional collaboration with Process, Automation, and QA Validation.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).
• Minimum 7–10 years of CQV experience in biotech or pharmaceutical manufacturing environments.
• Experience generating and executing CQV documentation (URS, FAT/SAT, IOQ, PQ).
• Strong knowledge of cleaning validation, sterilization principles, and automation integration.
• Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.
• Experience with FDA/EMA guidelines and ASTM E2500, ISPE Baseline Guides, GAMP 5.

Responsibilities

• Plan, coordinate, and execute CQV activities for CIP/SIP systems.
• Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.
• Execute IOQ and PQ protocols, including frequency/temperature mapping and validation of utilities.
• Generate and review CQV documentation with traceability from design to testing.
• Collaborate with Process Engineers, Automation, QA Validation, and Manufacturing.
• Provide training and guidance to CQV engineers and contractors.

Skills

Bilingual English/Spanish

Cross-functional collaboration

Documentation and data integrity

Education

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

Tools

DeltaV

SCADA

PLC systems

Job description

Validation & Engineering Group, Inc. (a Pinnaql company) seeks a Validation Specialist for CIP/SIP in a biotech manufacturing setting.

You will plan, coordinate, and execute CQV activities, ensuring GMP, FDA/EMA compliance and data integrity. Responsibilities include reviewing vendor FAT/SAT, IOQ/PQ execution, utility qualification, documentation per ASTM E2500 and GAMP 5, and cross-functional collaboration with Process, Automation, and QA Validation.