CIP/SIP Validation Specialist — Biotech Manufacturing

Pinnaql, Inc.; Manatí (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

Validation & Engineering Group, Inc. a Pinnaql company, is seeking a Validation Specialist - CIP/SIP for a biotech manufacturing environment.

You will plan, coordinate, and execute CQV activities to ensure CIP/SIP systems meet GMP, FDA, EMA standards and readiness for process validation. The role requires Bachelor’s in Chemical/Mechanical/Biochemical engineering and 7–10 years CQV experience, with expertise in ASTM E2500, GAMP 5, 21 CFR Part 11, and bilingual English/Spanish.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).
• 7–10 years of CQV experience in biotech or pharmaceutical manufacturing.
• Experience generating and executing CQV documentation.
• Strong knowledge of cleaning validation, sterilization principles, and automation integration.
• 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 URS, FAT/SAT, IOQ, and PQ 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.
• Provide training and technical guidance to CQV engineers and contractors.
• Support operations during process validation batches and cleaning validation campaigns.

Skills

CQV Experience

Documentation

GMP/FDA/EMA knowledge

Bilingual EN/ES

P&IDs review

ASTM E2500 familiarity

DeltaV/SCADA/PLC

Kneat/ValGenesis

Education

Bachelor’s degree in Chemical/Mechanical/Biochemical Engineering

Tools

DeltaV

SCADA

Kneat

ValGenesis

Job description

Validation & Engineering Group, Inc. a Pinnaql company, is seeking a Validation Specialist - CIP/SIP for a biotech manufacturing environment.

You will plan, coordinate, and execute CQV activities to ensure CIP/SIP systems meet GMP, FDA, EMA standards and readiness for process validation. The role requires Bachelor’s in Chemical/Mechanical/Biochemical engineering and 7–10 years CQV experience, with expertise in ASTM E2500, GAMP 5, 21 CFR Part 11, and bilingual English/Spanish.