Validation Engineers
17-2112.02
Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
Sample of reported job titles: Corporate Quality Engineer, Product Quality Engineer, Quality Assurance Engineer, Quality Engineer, Quality Management Systems Engineer, Reliability Engineer, Supplier Quality Engineer, Validation Specialist
Occupation-Specific Information
Tasks
- Study product characteristics or customer requirements to determine validation objectives and standards.
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
- Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
- Maintain validation test equipment.
- Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
- Communicate with regulatory agencies regarding compliance documentation or validation results.
- Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
- Recommend resolution of identified deviations from established product or process standards.
- Design validation study features, such as sampling, testing, or analytical methodologies.
- Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.
- Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
- Resolve testing problems by modifying testing methods or revising test objectives and standards.
- Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
- Draw samples of raw materials, intermediate products, or finished products for validation testing.
- Direct validation activities, such as protocol creation or testing.
- Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
- Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
- Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.
- Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
- Plan or conduct validation testing of alternative energy products, such as synthetic jet fuels or energy storage systems, such as fuel cells.
- Devise automated lab validation test stations or other test fixtures or equipment.
Technology Skills
- Analytical or scientific software - Cadence Incisive Enterprise Simulator; Cadence Incisive Enterprise Specman Elite Testbench; IndySoft Gage InSite Enterprise; Laboratory information management system LIMS; Logic simulators; Minitab; QUALCOMM eXtensible Diagnostic Monitor QxDM; Simulation program with integrated circuit emphasis SPICE; Simulation software; Statistical software; Synopsys electronic design software; The MathWorks MATLAB π₯
-
Application server software -
Kubernetes
; Docker ; GitHub π₯; Red Hat WildFly
- Cloud-based management software - Amazon Web Services AWS CloudFormation π₯; Splunk Enterprise π₯
- Compliance software - Sparta Systems TrackWise
- Computer aided design CAD software - Dassault Systemes CATIA; Dassault Systemes SolidWorks π₯; PTC Creo Parametric
-
Configuration management software -
Chef π₯; IBM Terraform ; Perforce Helix software; Puppet π₯
- Content workflow software - Atlassian JIRA π₯
- Data base management system software - Amazon DynamoDB π₯; Apache Cassandra π₯; Apache Solr; Elasticsearch π₯; MongoDB π₯; MySQL π₯; NoSQL π₯; Teradata Database π₯
-
Data base user interface and query software -
Amazon Elastic Compute Cloud EC2 π₯; Amazon Web Services AWS software ; Microsoft Access π₯; Microsoft SQL Server π₯; Prometheus; Structure query language SQL; Structured query language SQL
-
Development environment software -
Apache Ant; Apache Kafka π₯; Apache Maven π₯; C π₯; Go ; IBM Rational ClearQuest; Microsoft Azure software ; Microsoft PowerShell π₯; Microsoft Visual Basic π₯; Microsoft Visual Studio π₯; National Instruments LabVIEW; Ruby π₯; Verilog; Very high-speed integrated circuit VHSIC hardware description language VHDL
- Document management software - EMC Documentum
- Electronic mail software - Email software; IBM Notes; Microsoft Outlook π₯
-
Enterprise application integration software -
Atlassian Bamboo π₯; Extensible markup language XML π₯; Jenkins CI
-
Expert system software -
Ansible software
- File versioning software - Apache Subversion SVN π₯; Git π₯
- Graphical user interface development software - Grafana Labs Grafana Cloud
- Industrial control software - GE Intelligent Platforms Proficy HMI/SCADA iFIX
- Network monitoring software - Nagios; Wireshark
- Network security and virtual private network VPN equipment software - Virtual private networking VPN software
-
Object or component oriented development software -
Apache Groovy; C# π₯; C++ π₯; Oracle Java ; Perl π₯; Python ; R π₯; Scala π₯
- Object oriented data base management software - PostgreSQL π₯
-
Office suite software -
Microsoft Office software
-
Operating system software -
Bash π₯; Linux ; Microsoft Windows π₯; Operating system software; Red Hat Enterprise Linux; Shell script π₯; Ubuntu; UNIX π₯; UNIX Shell π₯
- Portal server software - Apache HTTP Server
-
Presentation software -
Microsoft PowerPoint
- Process mapping and design software - Microsoft Visio π₯
- Program testing software - Bugzilla; Hewlett Packard LoadRunner; Hewlett Packard QuickTest Professional; JUnit π₯; Selenium π₯; Windows kernel debuggers
- Project management software - Microsoft Project π₯; Project management software
-
Spreadsheet software -
Microsoft Excel
- Web platform development software - Apache Struts; Apache Tomcat π₯; Django π₯; JavaScript π₯; Node.js π₯; PHP π₯; Ruby on Rails π₯
- Word processing software - Microsoft Word π₯
Occupational Requirements
Work Activities
- Getting Information - Observing, receiving, and otherwise obtaining information from all relevant sources.
- Monitoring Processes, Materials, or Surroundings - Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
- Identifying Objects, Actions, and Events - Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
- Inspecting Equipment, Structures, or Materials - Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.
- Estimating the Quantifiable Characteristics of Products, Events, or Information - Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.
- Judging the Qualities of Objects, Services, or People - Assessing the value, importance, or quality of things or people.
- Processing Information - Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
- Evaluating Information to Determine Compliance with Standards - Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
- Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
- Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.
- Thinking Creatively - Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
- Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job.
- Developing Objectives and Strategies - Establishing long-range objectives and specifying the strategies and actions to achieve them.
- Scheduling Work and Activities - Scheduling events, programs, and activities, as well as the work of others.
- Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work.
- Performing General Physical Activities - Performing physical activities that require considerable use of your arms and legs and moving your whole body, such as climbing, lifting, balancing, walking, stooping, and handling materials.
- Handling and Moving Objects - Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things.
- Controlling Machines and Processes - Using either control mechanisms or direct physical activity to operate machines or processes (not including computers or vehicles).
- Operating Vehicles, Mechanized Devices, or Equipment - Running, maneuvering, navigating, or driving vehicles or mechanized equipment, such as forklifts, passenger vehicles, aircraft, or watercraft.
- Working with Computers - Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
- Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment - Providing documentation, detailed instructions, drawings, or specifications to tell others about how devices, parts, equipment, or structures are to be fabricated, constructed, assembled, modified, maintained, or used.
- Repairing and Maintaining Mechanical Equipment - Servicing, repairing, adjusting, and testing machines, devices, moving parts, and equipment that operate primarily on the basis of mechanical (not electronic) principles.
- Repairing and Maintaining Electronic Equipment - Servicing, repairing, calibrating, regulating, fine-tuning, or testing machines, devices, and equipment that operate primarily on the basis of electrical or electronic (not mechanical) principles.
- Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
- Interpreting the Meaning of Information for Others - Translating or explaining what information means and how it can be used.
- Communicating with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
- Communicating with People Outside the Organization - Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
- Establishing and Maintaining Interpersonal Relationships - Developing constructive and cooperative working relationships with others, and maintaining them over time.
- Assisting and Caring for Others - Providing personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.
- Selling or Influencing Others - Convincing others to buy merchandise/goods or to otherwise change their minds or actions.
- Resolving Conflicts and Negotiating with Others - Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
- Performing for or Working Directly with the Public - Performing for people or dealing directly with the public. This includes serving customers in restaurants and stores, and receiving clients or guests.
- Coordinating the Work and Activities of Others - Getting members of a group to work together to accomplish tasks.
- Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.
- Training and Teaching Others - Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
- Guiding, Directing, and Motivating Subordinates - Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
- Coaching and Developing Others - Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
- Providing Consultation and Advice to Others - Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
- Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
- Staffing Organizational Units - Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.
- Monitoring and Controlling Resources - Monitoring and controlling resources and overseeing the spending of money.
Detailed Work Activities
- Review technical documents to plan work.
- Analyze test or validation data.
- Prepare detailed work plans.
- Document technical design details.
- Maintain test equipment.
- Conduct validation tests of equipment or processes.
- Communicate technical information to suppliers, contractors, or regulatory agencies.
- Maintain operational records or records systems.
- Inspect finished products to locate flaws.
- Recommend technical design or process changes to improve efficiency, quality, or performance.
- Devise research or testing protocols.
- Operate computer systems.
- Resolve operational performance problems.
- Inspect operational processes.
- Collect samples of raw materials or finished products.
- Direct quality control activities.
- Update technical knowledge.
- Train personnel on proper operational procedures.
- Design electronic or computer equipment or instrumentation.