Validation Specialist (Cleaning-In-Place)

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

Current job opportunities are posted here as they become available.

Validation Specialist (Cleaning-In-Place)

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:
Commissioning & Qualification Execution:

• 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 closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

• 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.

Cross-functional Collaboration:

• 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.

Qualifications:

• Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).
• Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.
• Experience in 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.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.