CIP/SIP Validation Engineer – Biotech

Veg Group; Manatí (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a highly skilled Validation Specialist for CIP/SIP systems in a biotech manufacturing setting. The role emphasizes CQV planning, execution, and regulatory compliance in GMP environments.

The ideal candidate will have 7–10 years of CQV experience, a bachelor’s degree in engineering, and bilingual English/Spanish communication skills to collaborate with cross-functional teams and ensure quality throughout validation activities.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).
• 7–10 years of CQV experience in biotech/pharma manufacturing.
• Experience generating and executing CQV documentation.
• Strong knowledge of cleaning validation and sterilization principles.
• Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.
• Proficiency with FDA/ EMA guidelines and ISPE GAMP 5.

Responsibilities

• Plan, coordinate, and execute CQV activities for CIP/SIP systems in biotech manufacturing.
• Review and approve qualification protocols and ensure traceability from design through testing.
• Collaborate with QA, Process, Automation to ensure data integrity and successful commissioning.
• Provide training and leadership to CQV teams and contractors.

Skills

CQV experience

GMP knowledge

Automation integration

P&IDs review

Data integrity

Bilingual English/Spanish

Education

Bachelor’s degree in Chemical/Mechanical/Biochemical Engineering

Tools

DeltaV

SCADA

PLC systems

Job description

Validation & Engineering Group, Inc. is seeking a highly skilled Validation Specialist for CIP/SIP systems in a biotech manufacturing setting. The role emphasizes CQV planning, execution, and regulatory compliance in GMP environments.

The ideal candidate will have 7–10 years of CQV experience, a bachelor’s degree in engineering, and bilingual English/Spanish communication skills to collaborate with cross-functional teams and ensure quality throughout validation activities.