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Career: Validation Engineers

Job Description

Design and plan protocols for equipment and processes to produce products meeting internal and external purity, safety, and quality requirements.


Job Tasks

Importance %age

Task Description
100
Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of production problems.
100
Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
100
Prepare, maintain, or review validation and compliance documentation such as engineering change notices, schematics, and protocols.
100
Identify deviations from established product or process standards and provide recommendations for resolving deviations.
100
Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
100
Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
97
Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
97
Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
97
Resolve testing problems by modifying testing methods or revising test objectives and standards.
97
Prepare detailed reports and design statements based on results of validation and qualification tests or reviews of procedures and protocols.
97
Conduct validation and qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
97
Design validation study features such as sampling, testing, and analytical methodologies.
97
Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
97
Draw samples of raw materials, or intermediate and finished products for validation testing.
93
Prepare validation and performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, and other types of production.
93
Direct validation activities such as protocol creation or testing.
93
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
86
Procure or devise automated lab validation test stations or other test fixtures and equipment.
83
Communicate with regulatory agencies regarding compliance documentation or validation results.
59
Maintain validation test equipment.

Work Activities

Importance %age

Activity Description
77
Processing Information
  • Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
    		•
    74
    		Organizing, Planning, and Prioritizing Work
  • Developing specific goals and plans to prioritize, organize, and accomplish your work.
    		•
    73
    		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.
    		•
    73
    		Updating and Using Relevant Knowledge
  • Keeping up-to-date technically and applying new knowledge to your job.
    		•
    72
    		Communicating with Supervisors, Peers, or Subordinates
  • Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
    		•
    72
    		Identifying Objects, Actions, and Events
  • Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
    		•
    72
    		Monitor Processes, Materials, or Surroundings
  • Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
    		•
    72
    		Analyzing Data or Information
  • Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
    		•
    70
    		Making Decisions and Solving Problems
  • Analyzing information and evaluating results to choose the best solution and solve problems.
    		•
    66
    		Establishing and Maintaining Interpersonal Relationships
  • Developing constructive and cooperative working relationships with others, and maintaining them over time.
    		•
    66
    		Documenting/Recording Information
  • Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
    		•
    65
    		Judging the Qualities of Things, Services, or People
  • Assessing the value, importance, or quality of things or people.
    		•
    64
    		Getting Information
  • Observing, receiving, and otherwise obtaining information from all relevant sources.
    		•
    64
    		Provide Consultation and Advice to Others
  • Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
    		•
    62
    		Interpreting the Meaning of Information for Others
  • Translating or explaining what information means and how it can be used.
    		•
    61
    		Coordinating the Work and Activities of Others
  • Getting members of a group to work together to accomplish tasks.
    		•
    60
    		Scheduling Work and Activities
  • Scheduling events, programs, and activities, as well as the work of others.
    		•
    60
    		Inspecting Equipment, Structures, or Material
  • Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.
    		•
    59
    		Thinking Creatively
  • Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
    		•
    57
    		Communicating with Persons Outside 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.
    		•
    57
    		Resolving Conflicts and Negotiating with Others
  • Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
    		•
    56
    		Developing and Building Teams
  • Encouraging and building mutual trust, respect, and cooperation among team members.
    		•
    54
    		Interacting With Computers
  • Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
    		•
    53
    		Guiding, Directing, and Motivating Subordinates
  • Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
    		•
    52
    		Coaching and Developing Others
  • Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
    		•
    50
    		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.
    		•
    49
    		Developing Objectives and Strategies
  • Establishing long-range objectives and specifying the strategies and actions to achieve them.
    		•
    48
    		Training and Teaching Others
  • Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
    		•
    47
    		Performing Administrative Activities
  • Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
    		•
    47
    		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.
    		•
    45
    		Monitoring and Controlling Resources
  • Monitoring and controlling resources and overseeing the spending of money.
    		•
    43
    		Controlling Machines and Processes
  • Using either control mechanisms or direct physical activity to operate machines or processes (not including computers or vehicles).
    		•
    42
    		Selling or Influencing Others
  • Convincing others to buy merchandise/goods or to otherwise change their minds or actions.
    		•
    33
    		Staffing Organizational Units
  • Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.
    		•
    32
    		Handling and Moving Objects
  • Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things.
    		•
    27
    		Assisting and Caring for Others
  • Providing personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.
    		•
    25
    		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 of materials.
    		•
    24
    		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.
    		•
    23
    		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.
    		•
    20
    		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.
    		•
    18
    		Operating Vehicles, Mechanized Devices, or Equipment
  • Running, maneuvering, navigating, or driving vehicles or mechanized equipment, such as forklifts, passenger vehicles, aircraft, or water craft.
    		•
    
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