CIP/SIP Validation Specialist — Biotech CQV Expert

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

Job summary

Validation & Engineering Group, Inc. seeks a seasoned Validation Specialist for CIP/SIP in a biotech manufacturing setting. You will plan, coordinate, and execute CQV activities, ensure compliance with GMP, FDA/EMA, and ASTM E2500, and drive data integrity across validation programs.

Requires 7–10 years CQV experience, bilingual English/Spanish, and strong collaboration with Engineering, QA, and Manufacturing teams. On-site position with extended hours as needed.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).
• 7–10 years CQV experience in biotech/pharma manufacturing.
• Experience generating and executing CQV documentation (FAT/SAT, IOQ, PQ).
• Knowledge of cleaning validation, sterilization, automation integration, and data integrity (21 CFR Part 11).

Responsibilities

• Review and approve CIP/SIP vendor FAT/SAT protocols.
• Execute IOQ and PQ for CIP/SIP systems, incl. steam sterilization and temp mapping.
• Manage deviations, non-conformances, and change controls for CIP/SIP.
• Collaborate with Process, Automation, QA Validation to ensure CQV success.

Skills

Bilingual English/Spanish

Process validation

Documentation control

Education

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

Tools

DeltaV

SCADA

PLC systems

Kneat

ValGenesis

Job description

Validation & Engineering Group, Inc. seeks a seasoned Validation Specialist for CIP/SIP in a biotech manufacturing setting. You will plan, coordinate, and execute CQV activities, ensure compliance with GMP, FDA/EMA, and ASTM E2500, and drive data integrity across validation programs.

Requires 7–10 years CQV experience, bilingual English/Spanish, and strong collaboration with Engineering, QA, and Manufacturing teams. On-site position with extended hours as needed.