GLP Computer Validation Engineer
General Dynamics IT is currently looking for a dedicated Good Laboratory Practice Computer Validation Engineer (GLP) to join our team to support the Information Management Division (IMD) at United States Army Medical Research Institute of Infectious Diseases at Frederick, Maryland.
The ideal individual will author, execute, and summarize validation protocols. 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).
Responsibilities include but are not limited to:
- 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 Good Laboratory Practices (GLP) CFR 21 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 computer related systems validation.
- Validation activities include but are not limited to: Requesting validation and change control numbers from the Document Control Office (DCO) Generating protocols and change control documents with input from equipment users
- Providing quality control 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.
- 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.
- B.S. in Science or Engineering
- Must be a US Citizen
- 1-2 years of validation experience in pharmaceutical, biotech or medical device industry
- Working knowledge of GLP, SPC, QS, FDA regulations
- Experience with development of 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.
As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.