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GMP Equipment Validation Specialist

Lenexa, KS · On-site

GMP Equipment Validation Specialist- ICON - Lenexa KS ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients ...

QRC Group

Validation Engineer

Caguas, PR · On-site

$85 - $115/hr

Caguas, Puerto Rico | Posted on 07/30/2026 We are seeking a Validation Engineer to support equipment validation activities in a medical device manufacturing environment (21 CFR Part 820 / ISO 13485)

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Equipment Validation information

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How much do equipment validation jobs pay per hour?

As of Aug 29, 2026, the average hourly pay for equipment validation in the United States is $63.77, according to ZipRecruiter salary data. Most workers in this role earn between $52.64 and $69.71 per hour, depending on experience, location, and employer.

What is equipment validation?

Equipment validation is the process of ensuring that machinery and equipment used in manufacturing or laboratory settings perform as intended and meet regulatory standards. This process typically involves documented testing, calibration, and qualification procedures to verify that the equipment consistently produces reliable and accurate results. Equipment validation is critical in industries such as pharmaceuticals, biotechnology, and medical devices, where product quality and patient safety are paramount. Proper validation helps organizations comply with regulatory requirements and avoid costly errors or recalls.

What are the key skills and qualifications needed to thrive in equipment validation?

To excel in Equipment Validation, you need a strong background in engineering or life sciences, knowledge of regulatory compliance (such as GMP or FDA standards), and experience in validation protocols. Familiarity with validation software, data analysis tools, and systems like LIMS or TrackWise is commonly required, along with certifications like Six Sigma or CQV being advantageous. Attention to detail, problem-solving ability, and effective communication are crucial soft skills for this role. These competencies ensure validated equipment consistently meets quality and regulatory requirements, minimizing risks and supporting safe, compliant operations.

What are some common challenges faced in an equipment validation role and how can they be managed?

One of the main challenges in Equipment Validation is ensuring compliance with strict regulatory standards while meeting tight project timelines. Professionals in this role often coordinate with cross-functional teams, such as engineering, quality assurance, and production, to gather technical documentation and execute validation protocols. Managing unexpected equipment failures or documentation gaps can also be demanding. Staying organized, maintaining clear communication, and proactively addressing potential issues are key strategies for overcoming these challenges and ensuring successful validation outcomes.

What is the difference between Equipment Validation vs Equipment Calibration?

AspectEquipment ValidationEquipment Calibration
PurposeTo ensure equipment performs as intended and meets regulatory requirementsTo adjust and verify equipment accuracy and precision
ProcessComprehensive testing and qualificationRoutine measurement and adjustment
FrequencyTypically during installation, qualification, or as requiredRegular intervals based on manufacturer or industry standards
DocumentationValidation protocols and reportsCalibration certificates and logs

Equipment Validation ensures that equipment functions correctly within regulated environments, confirming suitability for use. Equipment Calibration focuses on maintaining measurement accuracy over time. Both are essential for compliance and quality assurance but serve different purposes in equipment management.

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Equipment Validation jobs near you
Infographic showing various Equipment Validation job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 16% Part Time, 2% Contract, and 1% Nights. Highlights an 98% Physical, 1% Hybrid, and 1% Remote job distribution, with an average salary of $132,650 per year, or $63.8 per hour.

Equipment Validation Engineer

Raleigh, NC • On-site

ALLIANCE BIOTECH SOLUTIONS LLC
See more jobs at ALLIANCE BIOTECH SOLUTIONS LLCexternal

Full-time

Dental, Vision, Retirement, PTO

Re-posted 26 days ago

Job description

Description

Alliance Biotech Solutions has multiple openings for Validation Engineers to support the execution and coordination of commissioning, qualification, and validation (CQV) activities for new and existing equipment within a GMP-regulated CDMO environment. These roles will focus on the introduction of new process equipment and updates to existing systems, ensuring all validation activities are executed in compliance with FDA, GMP, and global regulatory standards.


This Validation Engineer will work cross-functionally with Manufacturing, Quality, Engineering, and Automation teams to support equipment qualification, system integration, and potential CSV activities. The role requires strong technical writing, analytical thinking, and hands-on execution to ensure compliant, efficient project delivery within aggressive timelines.

Requirements

Execute and support equipment qualification activities including IQ/OQ/PQ protocol development, execution, and report generation
Support validation efforts for single-use systems including single-use mixers (SUMs), process pumps, and filtration systems (SUTFF)
Participate in the qualification of lab instruments such as cell viability analyzers (e.g., Vi-Cell BLU) including potential CSV/data integrity support
Perform on-the-floor validation execution including system walkdowns, functional testing, and coordination with operations
Support system integration activities, ensuring equipment and instrumentation operate within defined parameters
Assist with updates and modifications to existing systems, including parameter and instrumentation changes
Investigate deviations, discrepancies, and non-conformances; perform root cause analysis and support corrective actions
Ensure timely closure of validation deliverables and associated documentation
Collaborate with cross-functional teams to align validation activities with project timelines and operational priorities
Author and review validation protocols, reports, and technical documentation
Support execution within electronic validation and quality systems (e.g., KNEAT, TrackWise, Veeva or similar)

Experience/Skills

  2+ years (mid-level) or 5+ years (senior) of experience supporting CQV/validation activities in GMP-regulated environments
Experience with equipment qualification (IQ/OQ/PQ) for manufacturing and/or lab systems
Exposure to single-use technologies and/or biopharmaceutical manufacturing environments preferred
Experience with CSV and data integrity concepts is a plus
Strong understanding of GMP regulations and global compliance standards
Ability to interpret technical documentation including P&IDs, URS, and process flow diagrams
Strong technical writing and documentation skills
Demonstrated analytical and problem-solving capabilities
Ability to work independently and manage multiple priorities in a fast-paced project environment
Strong communication skills with the ability to collaborate cross-functionally


Benefits & Compensation

 Competitive wage as a full-time employee

 Paid Time Off

 Dental and Vision Insurance with low employee cost

 paid long term and short-term disability

 401K plan with employer contributions


About Alliance Biotech Solutions

Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success.

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