CIP/SIP Validation Specialist – Biotech

Pinnaql, Inc.; Humacao (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Validation Specialist for CIP/SIP in a biotech manufacturing setting. The role requires coordinating CQV activities, approving vendor FAT/SAT, and ensuring compliance with GMP, FDA/EMA guidelines.

Responsibilities include IOQ/PQ execution, utility qualification, data integrity, and cross-functional collaboration with automation, QA, and process teams. Bilingual English/Spanish required; extended hours may be needed.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering
• 7–10 years of CQV experience in biotech or pharmaceutical manufacturing environments
• Experience generating and executing documentation for CQV activities
• Strong knowledge of cleaning validation, sterilization principles, and automation integration
• Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management
• Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines
• Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications
• Experience executing or overseeing FAT/SAT, IOQ, PQ activities
• Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (Kneat, ValGenesis)
• Must be fully bilingual (English / Spanish) with excellent oral skills

Responsibilities

• Review and approve vendor FAT/SAT protocols for CIP/SIP equipment
• Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping
• Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air)
• Collaborate with Automation, Process, and QA Validation for recipe verification and data integrity
• Generate and review CQV documentation in compliance with ASTM E2500 and GAMP 5
• Ensure traceability from design specifications through executed testing
• Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems
• Prepare summary reports for Quality Assurance approval
• Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure integration of CIP/SIP operations with process equipment
• Support operations during process validation batches and cleaning validation campaigns
• Provide training and technical guidance to CQV engineers and contractors executing test protocols

Skills

Bilingual English/Spanish

CQV experience (biotech/pharma)

Documentation generation/execution

Process validation knowledge

Education

Bachelor's degree in Chemical/Mechanical/Biochemical Engineering

Tools

DeltaV

SCADA

PLC systems

Kneat

ValGenesis

P&ID review

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Validation Specialist for CIP/SIP in a biotech manufacturing setting. The role requires coordinating CQV activities, approving vendor FAT/SAT, and ensuring compliance with GMP, FDA/EMA guidelines.

Responsibilities include IOQ/PQ execution, utility qualification, data integrity, and cross-functional collaboration with automation, QA, and process teams. Bilingual English/Spanish required; extended hours may be needed.