Lead Validation Specialist

Salas O'Brien•Cincinnati, OH

52d

About The Position

Salas 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. Validation Specialists develop and execute C&Q 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).

Requirements

A Lead Validation Specialist (VS-III or VS-IV) is organized, analytical, and self-motivated, possessing considerable knowledge of the food, pharmaceutical, and biotech industries and FDA regulations.
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.
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.
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).

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.