Role Description

Scientific > Validation Specialist

Salary National Average

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63630.0000 84800.0000 99310.0000

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Short Description:

Their goals are to achieve high quality products on a consistent basis. These specialists generate, execute and review qualification and validation studies according to approved protocols and SOPs (Standard Operating Procedures). They write instructions called protocol documents and reports to show how each biomanufacturing system, piece of equipment, method, software or process is validated - doing what it's supposed to do. They analyze the results of testing and determine their acceptability against predetermined criteria. They require adherence to strict documentation, reviews and approvals. Validation Specialists also investigate and troubleshoot problems and determine solutions or recommendations for changes and improvements, including expanding facilities and upgrading equipment and software.

Duties / Responsibilities:

  • Generating, implementing, documenting and approving of all installation, operation and performance qualifications, equipment and process validations, studies and cleaning validations. 
  • Training of personnel to perform validated procedures for equipment operation, product manufacture, and equipment cleaning. 
  • Approving documented procedures for hygiene and monitoring their implementation. 
  • Approving documented cleaning schedules and methods for relevant areas and equipment, 
  • Approving methods of microbiology with responsibility and authority to: 
  • Assist QC in identifying contamination sources and recommending means of eradication, 
  • Assist QC in investigating pre-sterilization microbiological contamination, 
  • Approve sterilization validation documentation. 
  • Scheduling with various departments for execution of IOQ and PQ protocols. 
  • Developing Validation Master Plan Validations Listings, and customer requirements for the manufacture of quality products. 
  • Manage the validations schedule to ensure that established turnaround times and due dates are met.

Skills / Requirements / Qualifications

  • Reading Comprehension — Understanding written sentences and paragraphs in work related documents.
  • Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
  • Speaking — Talking to others to convey information effectively.
  • Writing — Communicating effectively in writing as appropriate for the needs of the audience.
  • Active Listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
  • Monitoring — Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
  • Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
  • Science — Using scientific rules and methods to solve problems.
  • Active Learning — Understanding the implications of new information for both current and future problem-solving and decision-making.
  • Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.

Job Zones

  • Title:  Job Zone Four: Considerable Preparation Needed
  • Education:  Most of these occupations require a four-year bachelor's degree, but some do not.
  • Related Experience:  A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.
  • Job Training:  Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
  • Job Zone Examples:  Many of these occupations involve coordinating, supervising, managing, or training others. Examples include real estate brokers, sales managers, database administrators, graphic designers, chemists, art directors, and cost estimators.
  • Specific Vocational Preparation in years: (7.0 to < 8.0)

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