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Cleaning Validation Engineer Jobs in Puerto Rico

Pinnaql

CQV Project Manager

Juncos, PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Coordinate Technical Leads and CQV resources supporting cleaning and sterilization workstreams.

Pinnaql

CQV Sample Management / LIMS Coordinator

Juncos, PR · On-site

$17.75 - $24/hr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... We are seeking an experienced CQV Sample Management / LIMS Coordinator to support cleaning ...

Veg Group

CQV Project Manager

Juncos, PR · On-site

$125 - $150/hr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Coordinate Technical Leads and CQV resources supporting cleaning and sterilization workstreams.

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Cleaning Validation Engineer information

What is a cleaning validation engineer?

A Cleaning Validation Engineer ensures that manufacturing equipment and processes meet regulatory standards for cleanliness in industries like pharmaceuticals, biotech, and medical devices. They develop validation protocols, conduct tests, analyze data, and document results to confirm that cleaning procedures effectively remove contaminants. This role involves collaborating with quality assurance, production, and regulatory teams to maintain compliance with FDA, GMP, and other industry regulations.

What are the main challenges faced by cleaning validation engineers in the pharmaceutical industry?

Cleaning Validation Engineers in the pharmaceutical industry often face challenges such as staying up-to-date with evolving regulatory requirements, troubleshooting complex cleaning failures, and thoroughly documenting all validation activities. Balancing the needs for robust contamination control with operational efficiency requires analytical thinking and strong problem-solving abilities. Collaboration with manufacturing, quality assurance, and laboratory teams is frequent, as cleaning validation projects require input and support from multiple departments. Successfully managing these challenges ensures product safety, regulatory compliance, and continuous process improvement within manufacturing operations.

What are the key skills and qualifications needed to thrive as a cleaning validation engineer, and why are they important?

To thrive as a Cleaning Validation Engineer, you need a strong background in chemical engineering, microbiology, or a related field, often complemented by experience in GMP-regulated industries. Familiarity with validation protocols, analytical testing methods, and documentation tools (such as LIMS or QMS software) is essential, and certifications like Six Sigma or ASQ may be advantageous. Strong attention to detail, analytical thinking, and effective communication are key soft skills for success in the role. These capabilities are crucial to ensure regulatory compliance, product safety, and effective cross-functional collaboration in pharmaceutical or biotech manufacturing environments.

What are popular job titles related to Cleaning Validation Engineer jobs in Puerto Rico?

For Cleaning Validation Engineer jobs in Puerto Rico, the most frequently searched job titles are:

What job categories do people searching Cleaning Validation Engineer jobs in Puerto Rico look for?

The top searched job categories for Cleaning Validation Engineer jobs in Puerto Rico are:

Cleaning Validation Engineer jobs near you
Infographic showing various Cleaning Validation Engineer job openings in Puerto Rico as of August 2026, with employment types broken down into 83% Full Time, 6% Part Time, and 11% Contract. Highlights an 94% In-person, and 6% Hybrid job distribution.

Validation Specialist (Cleaning-In-Place)

Pinnaql

Manati, PR • On-site

Full-time

Re-posted 8 days ago

Key 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.

  • Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.

Job description

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.
Excited to build something meaningful together? We look forward to hearing from you.
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.

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