Senior CIP/SIP CQV Validation Engineer

Pinnaql, Inc.; Puerto Rico; On-site; USD 110,000 - 150,000; Full time

Job summary

Validation & Engineering Group, Inc. in Puerto Rico seeks a highly skilled Validation Specialist for CIP/SIP in a biotech manufacturing environment.

You will plan, coordinate, and execute CQV activities to ensure cleaning and sterilization systems meet GMP, FDA, EMA, and ASTM E2500 standards. Collaborating with Automation, Process Engineering, and QA Validation, you will generate validated documentation, approve IOQ/PQ, and support process validation batches and cleaning validation campaigns,

Qualifications

• Bachelor's degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).
• 7–10 years 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 (e.g., Kneat, ValGenesis).
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.
• Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning validation and temperature mapping.
• Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).
• Collaborate closely 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.
• Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful 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 expertise

GMP compliance

Documentation

Cross-functional collaboration

Data integrity

Automation integration

Education

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

Tools

DeltaV

SCADA

PLC

Kneat

ValGenesis

Job description

Validation & Engineering Group, Inc. in Puerto Rico seeks a highly skilled Validation Specialist for CIP/SIP in a biotech manufacturing environment.

You will plan, coordinate, and execute CQV activities to ensure cleaning and sterilization systems meet GMP, FDA, EMA, and ASTM E2500 standards. Collaborating with Automation, Process Engineering, and QA Validation, you will generate validated documentation, approve IOQ/PQ, and support process validation batches and cleaning validation campaigns,