RevereIT is always looking forward to hire professionals who can develop solutions that help customers achieve their business goals. Are you ready to make a difference in the lives of people?

We are currently hiring professionals for the below stated job profiles.

Sr. Validation Engineer I

RevereIT, LLC has job openings for Sr. Validation Engineer I. Jobs located in Herndon, VA and various unanticipated locations throughout the U.S. Analyze validation test data to determine whether systems or processes have met validation criteria and to conduct root cause analysis and prepare CAPA. Prepare validation and performance qualification protocols for new or modified manufacturing processes (for various class I and II medical devices such as defibrillator, wheelchairs, Catheters, Scopes etc.), systems, or equipment for various production types. Utilize FDA Compliance Regulations, including CFR 210/211/820, Part 11, and ISO 13485. Requires hands on experience with GAMP and analytical lab instruments, including HPLC, GC, MS, FTIR, Degassers, Auto Claves, and Bio-reactors. Study product characteristics/customer requirements and confer with management to determine validation objectives and standards. Create, populate, and maintain databases for tracking validation activities, test results, and validated systems. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Biomedical Engineering, Biological Engineering, Chemical Engineering, or related. Likely candidates will be tested on their general ability to perform the above tasks. Mail resume with cover letter to RevereIT, LLC, 13454 Sunrise Valley Drive, Suite 215, Herndon, VA 20171; Job 15REV47; EOE

Sr. Validation Engineer I (Pharma)

RevereIT, LLC has job openings for Sr. Validation Engineer I (Pharma). Jobs located in Herndon, VA and various unanticipated locations throughout the U.S. Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of problems for various pharma and other facilities. Prepare validation and performance qualification protocols for new or modified processes, systems, or equipment for various production types. Coordinate the implementation or scheduling of validation testing with affected departments and personnel. Study product characteristics/customer requirements and confer with management to determine validation objectives and standards. Create, populate, and maintain databases for tracking validation activities, test results, and validate systems. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Knowledge in analytical lab instruments and FDA Compliance Regulations preferred. Requires Master’s degree or foreign equivalent in Pharmaceutical Engineering, Chemical Engineering, Bio-Engineering, Biomedical Engineering, Biotechnology, or related. Likely candidates will be tested on their general ability to perform the above tasks. Mail resume with cover letter to RevereIT, LLC, 13454 Sunrise Valley Drive, Suite 215, Herndon, VA 20171; Job 15REV46; EOE

Sr. Software QA Engineer II

RevereIT, LLC has job openings for Sr. Software QA Engineer II. Jobs located in Herndon, VA and various unanticipated locations throughout the U.S. Design and assist in developing test plans, scenarios, scripts, or test procedures. Develop testing programs that address areas such as database impacts, software scenarios, regression testing, negative testing, error or bug retests, or usability. Report and track software defects, using a bug tracking system. Create test procedures to ensure replicability and compliance with internal standards. Develop test scripts in automation testing tools. Create test scripts in for database testing. Work with various technologies such as HP Quality Center, Quick Test Professional, Rational Test Suite, Selenium, SQL, and PL/SQL. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Computer Science, Engineering (any), or related and 1 year of experience in the job offered or as a Computer Software Professional. Likely candidates will be tested on their general ability to perform the above tasks. Mail resume with cover letter to RevereIT, LLC, 13454 Sunrise Valley Drive, Suite 215, Herndon, VA 20171; Job 15REV48; EOE

Sr. Validation Analyst I (Regulatory Affairs)

RevereIT, LLC has job openings for Sr. Validation Analyst I (Regulatory Affairs). Jobs located in Herndon, VA and various unanticipated locations throughout the U.S. Analyze requirements for various equipment or systems in compliance with Federal rules and regulations related to various pharmaceutical and/or medical device manufacturing facilities. Coordinate, prepare, or review documents related to regulatory submissions for various domestic and/or international projects. Write or update standard operating procedures, work instructions, or policies. Prepare and review protocols and identify gaps performing Root Cause Analysis. Track defects using Defect Management Tool and create deviation summary report. Provide technical review of data or reports that will be incorporated into FDA submissions to assure scientific rigor, accuracy, and clarity of presentation. Maintain or coordinate current knowledge base of existing and emerging regulations, regulatory standards, or guidance documents. Prepare and assist in development and review of Validation Protocols. Compile and maintain regulatory documentation databases or systems. Participate in internal or external audits. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Knowledge in FDA Compliance Regulations such as CFR 210, 211, 820, Part 11, ISO 13485, GAMP is a MUST. Requires Master’s degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences, Pharmacy, Chemistry, Biochemistry, Biology, or a related life sciences discipline. Likely candidates will be tested on their general ability to perform the above tasks. Mail resume with cover letter to RevereIT, LLC, 13454 Sunrise Valley Drive, Suite 215, Herndon, VA 20171; Job 15REV45; EOE

 

 
Computer Systems Validation

Computer System Validation (CSV) in regulated operations provides confirmation by examination and provision of objective evidence.

Validation for Vaccine Manufacturers An Introduction

This guidance document has been prepared to aid vaccine manufacturers in the preparation and performance of the validation studies required by GMP.