Lead Validation Specialist

Description

• A VS-III or VS-IV is expected to manage projects on an administrative and technical level,
• A VS-III or VS-IV is directly responsible to the Best Practice Lead (VS-III) / Department Manager
• Interface with the end user to develop and execute validation protocols (IQ/OQ/PQ). Execution
• Develop system specifications per GAMP and / or Good Engineering Practices (GEP).
• Interface with Original Equipment Manufacturers (OEM), Construction Managers (CM), and
• Represent and defend validation results to client auditors and regulatory authorities.
• Develop Trace Matrices (TM) to illustrate the relation of system requirements (UR/FS/DS - User
• Lead validation specialists in the execution of project tasks.
• Conduct cGMP Audits, Gap Analysis, and Impact Assessments as required to scope validation
• Develop Summary Reports (SR) that clearly and concisely summarize C&Q efforts.
• A VS-III or VS-IV is responsible for facilitating the career development of a VS-I or VS-II.
• Develop project Commissioning and Validation Master Plans (CVMP) that describe C&Q scope,

Requirements

• Proficiency in the use of field measuring instrumentation.
• Considerable knowledge of FDA regulations / cGMPs, and Good Automated Manufacturing
• Associate degree in the same disciplines or skilled technician / military veteran with 7 to 10 years
• Must possess the technical aptitude and experience necessary to configure and operate portable
• Proficiency in Windows & Microsoft Office applications (Word and Excel).
• Body motor skills sufficient to enable incumbent to move around an office environment,
• Work performed in an indoor office setting, a client manufacturing facility, and/or a client
• Light lifting up to 20 lbs.
• Ability to stand and walk for extended periods of time.
• Must possess excellent written, verbal and presentation skills.
• Must be able to work both independently and as a team leader.
• Must possess the technical aptitude to evaluate engineering documents including specifications,
• A VS-III or VS-IV is expected to manage multiple projects of various sizes, simultaneously.
• Ability to analyze unique situations and develop appropriate response.
• Must display professional deportment when interfacing with customers, vendors, and trade
• Ability to speak to and hear employees/clients via phone or in person.
• Must demonstrate the ability to assess project scope, manage change, and solve problems.
• Bachelor’s degree in a scientific, technical, or engineering discipline with 5 to 7 years of
• Ability to work at a computer terminal for extended periods of time.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance