LabTemps is searching for a Validation SME for our client in Albany, NY for a 3 month contract.

• The Subject Matter Expert in Validations would have the following responsibilities:
• This role requires independent validation execution responsibilities, to optimize site validation strategy and mentor validation specialists on site
• Manage cleaning, process and equipment validation activities throughout the plant with minimal guidance. This includes managing, coordinating and executing validation and cGMP-related activities of Engineering Services, R&D, Production, Maintenance and QA/QC.
• Establish and implement validation procedures and appropriate documentation to support installation, operational, cleaning and performance testing
• Maintain awareness of current regulatory trends and practices. Assist in FDA and customer audits.
• Develop, review and approve validation protocols and all completed validation documentation. Authorize equipment for use and product release.
• Periodic review of Site Validation Master Plan to update quarterly.
• Redesign and implement documentation and procedures in order to increase efficiency and reduce manual inputs, while maintaining regulatory requirements.
• Develop templates for various validation execution activities.
• Mentor validation team members, provide training on validation issues and documentation.
• Manage Quality Assurance initiatives plant-wide as they impact validation.
• Track all validation documentation throughout the plant and follow-up as needed.
• Perform other quality functions as necessary or as requested. Perform other duties as may be reasonably assigned in the course of business.

This resource should have the following qualifications:

• Bachelors of Science degree in Chemistry, Engineering or a related field.
• Minimum 5-10 years validation & quality experience.
• Language/Communications Skills o Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
• Ability to write speeches and articles for publication that conform to prescribed style and format.
• Ability to effectively present information to top management, public groups, and/or boards of directors.
• Mathematical Skills o Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. A o Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
• Reasoning Ability
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. o Ability to read and verify engineering drawings.