Lead Validation Specialist

Salas O'Brien-posted about 15 hours ago
Full-time • Mid Level
Cincinnati, OH
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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).

  • 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.
  • 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).
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