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Trackwise Validation Engineer Jobs (NOW HIRING)

Automated Systems, Inc.

Validation Engineer

Chicago, IL · On-site

$45 - $65/hr

Validation Engineer Location: Greater Chicagoland Area Contract: 6+ month duration with potential ... TrackWise), and validation execution platforms (e.g., Kneat) or equivalent tools · Excellent ...

kindeva

Sr. Validation Engineer

Lexington, KY · On-site

As a Validation Engineer, you will play a critical role in ensuring our pharmaceutical ... Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva). * Lean Six ...

kindeva

Sr. Validation Engineer

Lexington, KY

As a Validation Engineer, you will play a critical role in ensuring our pharmaceutical ... Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva). * Lean Six ...

kindeva

Sr. Validation Engineer

Lexington, KY

As a Validation Engineer, you will play a critical role in ensuring our pharmaceutical ... Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva). * Lean Six ...

kindeva

Sr. Validation Engineer

Lexington, KY · On-site

As a Validation Engineer, you will play a critical role in ensuring our pharmaceutical ... Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva). * Lean Six ...

AbbVie

Validation Engineer III

Branchburg, NJ · On-site

... or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process ... Quality System Experience (Veeva, Trackwise, ComplianceWire) * Statistical Analysis (Minitab or ...

AbbVie

Validation Engineer III

Branchburg, NJ

... or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process ... Quality System Experience (Veeva, Trackwise, ComplianceWire) * Statistical Analysis (Minitab or ...

AbbVie

Validation Engineer III

Branchburg, NJ · On-site

$84K/yr

... or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process ... Quality System Experience (Veeva, Trackwise, ComplianceWire) * Statistical Analysis (Minitab or ...

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Trackwise Validation Engineer information

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How much do trackwise validation engineer jobs pay per hour?

As of Jun 21, 2026, the average hourly pay for trackwise validation engineer in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What are some common challenges faced by Trackwise Validation Engineers during system implementation projects?

Trackwise Validation Engineers often encounter challenges such as ensuring compliance with stringent regulatory requirements, managing tight project timelines, and coordinating with cross-functional teams including IT, Quality Assurance, and business users. They must meticulously document validation activities and resolve issues that arise during testing phases, such as discrepancies between user requirements and system functionality. Effective communication and attention to detail are crucial to navigate complex validation protocols and maintain data integrity throughout the implementation process.

What are the key skills and qualifications needed to thrive as a Trackwise Validation Engineer, and why are they important?

A Trackwise Validation Engineer typically requires a strong background in computer science, engineering, or life sciences, along with experience in quality assurance and validation within regulated industries. Proficiency with Trackwise quality management software, knowledge of GxP regulations, and familiarity with validation tools and documentation standards are essential. Effective problem-solving, attention to detail, and strong communication skills enable success in collaborating with cross-functional teams and ensuring compliance. These competencies ensure that Trackwise systems meet regulatory standards, minimize risks, and support business quality objectives.

What is the difference between Trackwise Validation Engineer vs Validation Specialist?

AspectTrackwise Validation EngineerValidation Specialist
CredentialsDegree in Engineering, Life Sciences, or related field; GMP/Regulatory certificationsSimilar credentials; GMP/Regulatory certifications often required
Work EnvironmentPharmaceutical, biotech, or medical device industries; focus on software validationPharmaceutical and biotech sectors; focus on validation processes
Employer & Industry UsageUsed by companies implementing Trackwise software for validationCommon in validation teams across regulated industries
Search & Comparison IntentOften searched for comparing software validation rolesCompared for validation tasks and responsibilities

The Trackwise Validation Engineer specializes in validating Trackwise software within regulated industries, focusing on software validation processes. Validation Specialists have broader validation roles across various systems and equipment. While both roles require similar credentials and work in regulated environments, the Validation Engineer's expertise is more software-specific, especially related to Trackwise.

What is a Trackwise Validation Engineer?

A Trackwise Validation Engineer is a professional responsible for ensuring that the Trackwise quality management system (QMS) software is properly implemented and meets regulatory compliance standards, especially in industries like pharmaceuticals and life sciences. Their role involves validating the software through testing, documentation, and risk assessments to ensure it functions as intended and supports quality processes. They also work with cross-functional teams to troubleshoot issues, create validation protocols, and maintain compliance with industry regulations such as FDA 21 CFR Part 11. This position is crucial for maintaining the integrity and reliability of quality management systems within regulated environments.
Infographic showing various Trackwise Validation Engineer job openings in the United States as of June 2026, with employment types broken down into 99% Full Time, and 1% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.
Validation Engineer

Validation Engineer

Automated Systems, Inc.

Chicago, IL • On-site

$45 - $65/hr

Contractor

Medical, Dental, PTO

Posted 18 days ago

Job description

Validation Engineer

Location: Greater Chicagoland Area

Contract: 6+ month duration with potential for extensions

Work Location: onsite, 1st shift, five days a week - 40 hours weekly

 

Automated Systems, Inc. is seeking a Validation Engineer with a minimum of 3+ years of experience and has a strong understanding of validation principles to support a global pharmaceutical manufacturing client located in the Greater Chicagoland Area. In this role, you will support a production site consisting of multiple buildings, including aseptic processing, API pharmaceutical manufacturing, and cosmetics production. This is a hands-on, high-impact role for an experienced Validation Engineer who must demonstrate a deep expertise in validation principles and regulated manufacturing environments.

Key Job Responsibilities

·       Lead and participate in cross-functional forums including Product Introduction, Validation Planning, Change Control (CRB/CFT), and Validation Review Board (VRB) meetings

·       Serve as the Validation representative during daily shop floor operations

·       Provide validation expertise to support investigations, CAPAs, and change activities

·       Develop, maintain, and manage Validation Master Plans (VMPs), procedures, and internal work trackers

·       Author, route, review, and approve validation documentation within OneVault, including C&Q documents and DCCs

·       Review and approve Change Records, assessments, and related actions/extensions in OneTrack

·       Perform Validation Impact Assessments for document and change controls

·       Support site-wide use of validation software, including template creation, hardware coordination, issue resolution, and user training

 

Education and Experience Requirements:

·       Bachelor’s degree in Pharmacy, Engineering, or a related scientific discipline

·       3+ years of validation experience in regulated manufacturing environments

·       Hands-on experience supporting aseptic processing, API manufacturing, and pharmaceutical equipment, facility, and utility qualification

·       Strong knowledge of the validation lifecycle, commissioning & qualification (C&Q), change control, and deviation management

·       Experience with electronic quality and validation systems, including document management (e.g., OneVault), change management (e.g., OneTrack), investigations/CAPA (e.g., TrackWise), and validation execution platforms (e.g., Kneat) or equivalent tools

·       Excellent communication and leadership skills with the ability to collaborate effectively across cross-functional teams

 

Company Description

We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.