Validation Engineer

We are currently searching for a Validation Engineer to provide quality and technical support to the National Institutes of Health.

 

Duties & Responsibilities

• Provide expertise in the validation of processes, equipment and build/commissioning of Aseptic Processing Facilities (APFs) across the NIH.
• Facilitate the development and review of project plans, qualification protocols and reports for all stages of the qualification process, while maintaining quality standards with FDA cGMP, USP, ICH and other regulatory guidance.
• Develop and implement Validation Plans for the Environmental Monitoring Systems in multiple new and existing facilities.
• Develop and implement Validation Master Plans for new APFs including the 12E CCE facility, interim/Permanent NMD Radiopharmacy and future viral seed stock facility.
• Review and update validation documents for current APFs.
• Serve as a subject matter expert for the Legacy Facility Project.
• Provide expertise in the harmonization of various documents between ORSC and ORF including the URS, VMP, SLIA and RA as well as development of EMS and BAS parameters.
• Develop the validation plans for MasterControl UAT Execution for eForms.
• Support Lessons Learned/Continuous Improvements programs.
• Develop FCIS/DFOM Web Portal/Dashboard.

 

Requirements

• Bachelor’s degree in a related field.
• Minimum of five (5) years of experience developing and performing validations in a cGMP environment.
• Strong interpersonal skills to deal effectively with a wide range of audiences.
• Excellent analytical and writing skills to prepare meeting materials, technical and administrative correspondence, and reports.
• Strong organizational skills and the ability to prioritize complex tasks.
• Time management and organizational skills to work efficiently and independently or as part of a team.

 

Compensation

The proposed salary range for this position is $115,000 to $120,000. Final salary will be determined based on various factors such as geography, experience, certifications, etc.

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.