Commissioning / Qualification / Validation Specialist

Commissioning / Qualification / Validation Specialist 

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

Benefits:

This role is eligible for performance-based bonuses and a comprehensive U.S. based benefits package, including:

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

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.