Lead Validation Specialist

Cincinnati, OH - Merchant, 135 Merchant St, Suite 300, Cincinnati, OH 45246, USA

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&’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).

• Hours average 40 per week; may require additional hours including evening and weekends depending on business needs.
• Work performed in an indoor office setting, a client manufacturing facility, and/or a client construction site.
• Wearing PPE / gowning…