Lead Validation Specialist

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).

ESSENTIAL JOB FUNCTIONS: 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 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.
  
  

JOB 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.

This job description is intended to describe the general nature, complexity and level of work to be performed by employees assigned to this position and is not construed as an exhaustive list of responsibilities, duties and/or skills required. It does not prescribe or restrict the work that may be assigned and is subject to change at the discretion of the company.

Additionally, a VS-III Or VS-IV

• 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).

Working Conditions

Working Hours/Environment

• 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 may occasionally be required.
  
  

Travel: Moderate – 40% including the immediate tri-state and regional travel

Physical Demands

• Ability to work at a computer terminal for extended periods of time.
• Ability to stand and walk for extended periods of time.
• Light lifting up to 20 lbs.
• Ability to speak to and hear employees/clients via phone or in person.
• Body motor skills sufficient to enable incumbent to move around an office environment,
  
  

manufacturing environment and construction site.

• Ability to analyze unique situations and develop appropriate response.