Salas O'Brien · 1 week ago
Lead Validation Specialist
Cincinnati, IL
Full-time
Hybrid
Senior Level
5+ years expSalas O’Brien / Process Plus is a full-service engineering firm that provides Commissioning and Qualification / Validation (C&Q) services to the food, pharmaceutical and biotech industries. The Lead Validation Specialist will develop and execute C&Q protocols, conduct audits, and lead validation specialists to ensure compliance with FDA regulations and Good Manufacturing Practices.
Industrial EngineeringMechanical Engineering
Responsibilities
Conduct cGMP Audits, Gap Analysis, and Impact Assessments as required to scope validation efforts
Develop system specifications per GAMP and / or Good Engineering Practices (GEP)
Develop project Commissioning and Validation Master Plans (CVMP) that describe C&Q 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 C&Q 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
Qualification
Required
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)
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
A VS-III or VS-IV 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 VS-III or VS-IV is responsible for facilitating the career development of a VS-I or VS-II
A VS-III or VS-IV is expected to manage multiple projects of various sizes, simultaneously
A VS-III or VS-IV is directly responsible to the Best Practice Lead (VS-III) / Department Manager (DM) administratively and the Project Manager (PM) for the successful execution of the project
Company
Salas O'Brien
Salas O'Brien is a national leading Facilities Planning, Commissioning, Construction Management and Mechanical, Electrical.
1001-5000 employees
H1B Sponsorship
Salas O'Brien has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (3)
2023 (2)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Blackstone Group
2024-01-22Private Equity
Leadership Team
Paul Silva
Chief Operating Officer
Karl F. Frey
Retired
Recent News
Sports Business Journal
2025-10-24
FoodProcessing.com
2025-10-16
Company data provided by crunchbase