Commissioning / Qualification / Validation Specialist

Salas O'Brien, Inc.; Columbus (OH); Hybrid; USD 90,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off

Job summary

Salas O’Brien is seeking a CQV Specialist to lead commissioning and validation activities in Columbus, OH. You will develop CQV Master Plans, conduct cGMP audits, and interface with OEMs, CMs, and contractors to execute CQV protocols.

The role requires a Bachelor’s in engineering or science and 5–7 years of FDA-regulated experience. You’ll guide a team, manage multiple projects, and ensure compliance with GAMP, FDA cGMPs, and Good Engineering Practices.

Qualifications

• Bachelor’s degree in engineering, science, or related field with FDA experience.
• Experience in CQV or commissioning in regulated environments.
• Knowledge of cGMPs and GAMP guidelines.

Responsibilities

• Conduct cGMP Audits, Gap Analysis, and Risk/Impact Assessments as required to scope CQV efforts.
• Develop system specifications per GAMP and Good Engineering Practices (GEP).
• Develop project CQV Master Plans (CQVP) describing CQV scope and strategy.
• Interface with OEM, CM, and contractors to execute commissioning protocols and checklists.
• Interface with end users to develop validation protocols (IQ/OQ/PQ) and analyze data.
• Develop Trace Matrices linking UR/FS/DS to field verifications.
• Prepare Summary Reports summarizing CQV efforts and defend results to auditors.

Skills

Project management

Analytical thinking

Team leadership

Communication

Regulatory knowledge

Education

Bachelor’s degree in engineering/science

5-7 years FDA-regulated experience

Tools

Windows & MS Office

Field measuring instrumentation

GAMP knowledge

Job description

Job Category: Commissioning

Requisition Number: COMMI003773

• Posted : August 10, 2026
• Full-Time
• Hybrid

Locations

Showing 1 location

Columbus, OH 43228, USA

Description

At Salas O’Brien we tell our clients that we’re engineered for impact. This passion for making a difference applies just as much to our team as it does to our projects. That’s why we’re committed to living our values every day: inspiring, achieving, and connecting as shared owners of our success with a focus on a sustainable future.

Building for the long-term means that all of our team members can expect to work on amazing projects with a people-first approach to problem solving. It also means that each member of our team has truly limitless potential to build a unique, meaningful, and high-impact career—and they’ll receive great total rewards along the way.

About Us:

Founded in 1975, Salas O’Brien is an employee-owned engineering and professional services firm focused on achieving impact for our clients, our team, and the world. We know that tomorrow’s requirements are today’s opportunities, and we are here to design lasting solutions for pressing challenges.

We work across a variety of industries providing integrated engineering and consulting services. Our specialized experience includes design for data centers, healthcare, science and technology, high-rise buildings, clean energy, education, and other building types as well as structural and building sciences, infrastructure asset management, advanced robotics, and more.

Our technical expertise is paired with an exceptional team of business development, human resources, finance and accounting, information technology, and marketing professionals, all of whom play a key role in bringing our commitments to life every day.

Job Summary:

Salas O’Brien is a full-service engineering firm that provides Commissioning and Qualification / Validation (CQV) services to the life sciences (pharmaceutical / biotech industries), food, and cosmetics industries . CQV Specialists develop and execute CQV protocols (e.g., IQ/OQ/PQ) for these industries. Protocols may include verification of manufacturing / packaging facilities, process and packaging equipment, control systems, utilities, and HVAC / environmental conditions. Commissioning is executed to document delivery of a safe, functional system per Good Engineering Practices (GEP) and qualification is executed to verify conformance to the FDA’s current Good Manufacturing Practices (cGMPs).

Responsibilities:

The responsibilities listed are fundamental to the position and must be performed successfully to achieve the key performance objectives of the role. Other responsibilities may be assigned.

• Conduct cGMP Audits, Gap Analysis, and Risk / Impact Assessments as required to scope CQV efforts.
• Develop system specifications per GAMP and / or Good Engineering Practices (GEP).
• Develop project CQV Master Plans (CQVP) that describe CQV scope, intent, and strategy.
• Interface with Original Equipment Manufacturers (OEM), Construction Managers (CM), and construction contractors to develop and execute commissioning protocols and checklists.
• Interface with the end user to develop and execute validation protocols (IQ/OQ/PQ). Execution includes compiling and analyzing qualification / validation data.
• Develop Trace Matrices (TM) to illustrate the relation of system requirements (UR/FS/DS – User Requirements / Functional Specifications / Design Specifications) and field verifications (IQ/OQ/PQ).
• Develop Summary Reports (SR) that clearly and concisely summarize CQV efforts.
• Represent and defend validation results to client auditors and regulatory authorities.
• Lead validation specialists in the execution of project tasks.
• Perform other related duties as required and / or assigned.

Job Requirements:

• A CQV Specialist (CQVS-3 or CQVS-4) is organized, analytical, and self-motivated, possessing considerable knowledge of the food, pharmaceutical, and biotech industries and FDA regulations.
• A CQVS-3 or CQVS-4 is expected to manage projects on an administrative and technical level, including communication with the customer (e.g., status updates for schedule, progress and cost).
• A CQVS-3 or CQVS-4 is responsible for facilitating the career development of a VS-1 or VS-2.
• A CQVS-3 or CQVS-4 is expected to manage multiple projects of various sizes, simultaneously.
• A CQVS-3 or CQVS-4 is responsible to the Best Practice Lead (CQVS-5) / Department Manager (DM) administratively and the Project Manager (PM) for the successful execution of the project.

Additionally, a CQVS-3 or CQVS-4:

• Must be able to work both independently and as a team leader.
• Must possess the technical aptitude to evaluate engineering documents including specifications, wiring diagrams, P&ID’s, HVAC / mechanical system drawings, and architectural layouts.
• Must possess the technical aptitude and experience necessary to configure and operate portable measuring instrumentation used to gather verification data.
• Must possess excellent written, verbal and presentation skills.
• Must demonstrate the ability to assess project scope, manage change, and solve problems.
• Must display professional deportment when interfacing with customers, vendors, and trade contractors.

Education/Experience:

• Bachelor’s degree in a scientific, technical, or engineering discipline with 5 to 7 years of experience working within an FDA regulated environment.
• Associate degree in the same disciplines or skilled technician / military veteran with 7 to 10 years of experience working within an FDA or other regulated environment.
• Proficiency in Windows & Microsoft Office applications (Word and Excel).
• Proficiency in the use of field measuring instrumentation.
• Considerable knowledge of FDA regulations / cGMPs, and Good Automated Manufacturing Practices (GAMP).

Location: Columbus, OH

Travel: Up to 25%

Compensation: $90,000-$100,000

This role is eligible forperformance-based bonuses and a comprehensiveU.S. basedbenefits package, including:

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off and company holidays
• Wellness programs and employee assistance resources

For more information, visit our full benefits overview here .

Equal Opportunity Employment Statement

Salas O’Brien provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state/provincial, or local laws. Salas O’Brien will accommodate the disability-related needs of applicants as required by law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.