GLP Computer Validation Engineer
- Military veterans preferred
2019-04-17 General Dynamics Information Technology (www.gdit.com)
Frederick Maryland United States
General Dynamics IT is currently looking for a dedicated Good Laboratory Practice (GLP) Computer Validation Engineer to join our team to support the Information Management Division (IMD) at United States Army Medical Research Institute of Infectious Diseases (USAMRIID) at Frederick, Maryland.
The ideal individual will author, execute, and summarize validation deliverables. Coordinate and manage validation project execution for equipment, critical utility, process, and computer related systems. Ensure protocols, records, and procedures are in compliance with 21 CFR 11, & 58 Good Laboratory Practices (GLP), and USAMRIID policies and procedures
Equipment Qualification and Validation per FDA regulations and guidance; provide technical/scientific, administrative, and logistical support to provide qualification and validation services for laboratory equipment/systems in support of non-clinical and clinical studies; and product development efforts.
Provide validation services per FDA regulations, guidance and expectations for studies conducted using 21 CFR Part 58 and Part 11 quality system requirements and expectations.
Possess education, training and experience necessary to meet FDA regulatory expectations for GLP validation efforts including GLP Training; initial and refresher as appropriate, curricula vita, job description and training assigned by USAMRIID. Coordinate and execute validation studies (IQ, OQ, PQ etc): writing protocols, analyzing and documenting results, and generate final summary reports. Validation activities include but not limited to equipment/system qualification, process validation, and computerized systems validation.
Validation activities include but are not limited to:
Providing quality control and technical review during the execution of the test cases in real time
Preparing the validation and change control documents and records for final approval Ensuring appropriate validation record archival
Validation schedules shall be updated to reflect current status and all reporting of validation metrics.
Attend regularly scheduled Validation and Focus Group meetings as needed.
Develop validation master plans/project plans (VMP), revalidation plans and standard operating procedures (SOP) as necessary.
Coordinate validation activities with Divisional groups and other Stakeholders for timely protocol executions.
Work with cross functional teams during the entire process life cycle and provide technical assistance and training as a subject matter expert.
Assist in identifying, analyzing, and correcting issues for process optimization.
Knowledge and expertise in CAPA process from identifying the problem, Root Cause Analysis, CAPA Plan creation, and CAPA implementation.
As needed, conduct Process Capability studies for research processes using Six Sigma and other applicable Statistical Process Control (SPC) methodology and recommend process improvements.
Follow and recommend improvements as applicable in policies and procedures to management and maintain compliance with site and regulatory standards.
Must be a US Citizen
1-2 years of computerized system validation experience in pharmaceutical, biotech or medical device industry (FDA-regulated environment)
Working knowledge of GLP, SPC, QS, FDA regulations
Experience with development of Validation Master Plans, IQ, OQ PQ, SOPs
Experience with the following a plus;
Six sigma and SPC methodology experience
Ability to review P&ID, FATS, SATS etc.
For more than 50 years, General Dynamics Information Technology has served as a trusted provider of information technology, systems engineering, training and professional services to customers across federal, state, and local governments, and in the commercial sector. Over 40,000 GDIT professionals deliver enterprise solutions, manage mission-critical IT programs and provide mission support services worldwide. GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.