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Become A Validation Specialist

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Working As A Validation Specialist

  • Making Decisions and Solving Problems
  • Getting Information
  • Identifying Objects, Actions, and Events
  • Interacting With Computers
  • Communicating with Supervisors, Peers, or Subordinates
  • Deal with People

  • $92,600

    Average Salary

What Does A Validation Specialist Do At Kelly Services

* Support the validation function by assisting with the development of validation documentation, executing qualification protocols, compiling data, and writing reports.
* Support new product scale-up, process optimization, technology transfer, and process validation activities.
* Participate on project teams responsible for implementation of product enhancements.
* Maintain validation schedules/timelines
* Maintain re-validation schedule and validation files.
* Mentor junior staff and support team growth though the supervision of assigned projects
* Report back to QA Manager on the general status of operations and specific issues of concern as needed

What Does A Validation Specialist Do At System One Services

* Perform the QA review/approval of analytical documentation:
* Analytical method validation protocols and reports for in-process and release/stability testing
* Analytical method procedures and associated change controls
* Method technical transfer protocols and reports
* Reference Standard and Critical Reagent qualification protocols and reports
* Certificates of Analysis for reference materials and critical reagents
* Standard Operating Procedures and other guidance documents
* Collaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations/exceptional conditions related to method validations, technical transfers or reference standard/critical reagent qualifications
* Collaborate with manufacturing support functions to develop the methods and acceptance criteria for the development of raw material specifications in preparation for Process Performance Qualification activities

What Does A Validation Specialist Do At Bosch

* May lead a team (Bosch employees and customer representatives) during testing.
* Additional Responsibilities:
* Work in a cleanroom environment, fully gowned
* Work in tight quarters on top of and underneath equipment
* Lift 50 lbs. on an intermittent basis
* Maintain a flexible schedule allowing for travel on short notice
* Travel extensively in North America as well as worldwide, when needed approximately 50% of the time
* Submit to safety, background, and drug/alcohol testing as required by the company and customer(s)
* Qualifications

What Does A Validation Specialist Do At Kforce

* Support usage of the IS Project Methodology
* Will assist with defining validation strategy based on procedures
* Assist with training on IS compliance topics (e.g. validation)
* Minimum 5 years of experience with validation of IS computer systems in an FDA regulated environment
* years with a strong validation experience with Commercial operations Projects and applications (CRM, for example) would be good enough
* Experience with Commercial operations solutions, such as CRM (Customer relationship management) and digital platforms (Mobile apps)
* Experience with CRM Veeva and Patient support program platforms is a differential
* Experience with the HP Quality Center system is a plus
* Preferred: Experience with Commercial Operations
* Preferred: Experience with Website/Mobile Application/Digital
* Preferred: Scientific education or experience, with test script design, technical document reviews, and strong interpersonal skills
* Understanding of GxP regulations and computer validation principals
* Understanding of software development lifecycles
* Understanding of document management principals

What Does A Validation Specialist Do At Tactical Engineering & Analysis Inc.

* Supports in the decomposition of test requirements within various TDL systems and interface specifications.
* This includes ECP, ICPs and Trouble Report fixes.
* Supports in the development of test cases.
* Utilizes test management database for test cases and traceability to test requirements.
* This includes accurately entering requirements from various specification documents, tracing test cases and generating the associated test procedure

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How To Become A Validation Specialist

Industrial engineers must have a bachelor’s degree. Employers also value experience, so cooperative education engineering programs at universities are also valuable.

Education

Industrial engineers need a bachelor’s degree, typically in industrial engineering. However, many industrial engineers have degrees in mechanical engineering, electrical engineering, manufacturing engineering, industrial engineering technology, or general engineering. Students interested in studying industrial engineering should take high school courses in mathematics, such as algebra, trigonometry, and calculus; computer science; and sciences such as chemistry and physics.

Bachelor’s degree programs include lectures in classrooms and practice in laboratories. Courses include statistics, production systems planning, and manufacturing systems design, among others. Many colleges and universities offer cooperative education programs in which students gain practical experience while completing their education.

A few colleges and universities offer 5-year degree programs in industrial engineering that lead to a bachelor’s and master’s degree upon completion, and several more offer similar programs in mechanical engineering. A graduate degree allows an engineer to work as a professor at a college or university or to engage in research and development. Some 5-year or even 6-year cooperative education plans combine classroom study with practical work, permitting students to gain experience and to finance part of their education.

Programs in industrial engineering are accredited by ABET.

Important Qualities

Creativity. Industrial engineers use creativity and ingenuity to design new production processes in many kinds of settings in order to reduce the use of material resources, time, or labor while accomplishing the same goal.

Critical-thinking skills. Industrial engineers create new systems to solve problems related to waste and inefficiency. Solving these problems requires logic and reasoning to identify strengths and weaknesses of alternative solutions, conclusions, or approaches to the problems.

Listening skills. These engineers often operate in teams, but they also must solicit feedback from customers, vendors, and production staff. They must listen to customers and clients in order to fully grasp ideas and problems the first time.

Math skills. Industrial engineers use the principles of calculus, trigonometry, and other advanced topics in mathematics for analysis, design, and troubleshooting in their work.

Problem-solving skills. In designing facilities for manufacturing and processes for providing services, these engineers deal with several issues at once, from workers’ safety to quality assurance.

Speaking skills. Industrial engineers sometimes have to explain their instructions to production staff or technicians before they can make written instructions available. Being able to explain concepts clearly and quickly is crucial to preventing costly mistakes and loss of time.

Writing skills. Industrial engineers must prepare documentation for other engineers or scientists, or for future reference. The documentation must be coherent and explain their thinking clearly so that the others can understand the information.

Licenses, Certifications, and Registrations

Licensure is not required for entry-level positions as an industrial engineer. A Professional Engineering (PE) license, which allows for higher levels of leadership and independence, can be acquired later in one’s career. Licensed engineers are called professional engineers (PEs). A PE can oversee the work of other engineers, sign off on projects, and provide services directly to the public. State licensure generally requires

  • A degree from an ABET-accredited engineering program
  • A passing score on the Fundamentals of Engineering (FE) exam
  • Relevant work experience, typically at least 4 years
  • A passing score on the Professional Engineering (PE) exam

The initial FE exam can be taken after one earns a bachelor’s degree. Engineers who pass this exam are commonly called engineers in training (EITs) or engineer interns (EIs). After meeting work experience requirements, EITs and EIs can take the second exam, called the Principles and Practice of Engineering.

Several states require engineers to take continuing education in order to keep their licenses. Most states recognize licenses from other states, as long as the other state’s licensing requirements meet or exceed their own licensing requirements.

Advancement

Beginning industrial engineers usually work under the supervision of experienced engineers. In large companies, new engineers also may receive formal training in classes or seminars. As beginning engineers gain knowledge and experience, they move on to more difficult projects with greater independence to develop designs, solve problems, and make decisions.

Eventually, industrial engineers may advance to become technical specialists, such as quality engineers or facility planners. In that role, they supervise a team of engineers and technicians. Obtaining a master’s degree facilitates such specialization and thus advancement.

Many industrial engineers move into management positions because the work they do is closely related to the work of managers. For more information, see the profile on architectural and engineering managers.

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Validation Specialist jobs

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Validation Specialist Career Paths

Validation Specialist
Senior Validation Engineer Project Manager Business Manager
Business Operations Manager
8 Yearsyrs
Project Manager General Manager Maintenance Technician
Chief Engineer
10 Yearsyrs
Validation Analyst Business Analyst Quality Assurance Manager
Corporate Quality Manager
12 Yearsyrs
Quality Assurance Specialist Quality Assurance Manager Quality Manager
Director Of Quality
14 Yearsyrs
Process Engineer Production Manager
Manufacturing Manager
10 Yearsyrs
Project Manager Program Manager Marketing Manager
Operations Manager
7 Yearsyrs
Quality Assurance Quality Manager Operations Manager
Operations Project Manager
8 Yearsyrs
Quality Assurance Analyst Performance Tester Performance Analyst
Performance Manager
8 Yearsyrs
Senior Validation Engineer Senior Quality Engineer Quality Supervisor
Plant/Quality Manager
11 Yearsyrs
Process Engineer Manufacturing Engineer Project Engineer
Project Engineering Manager
8 Yearsyrs
Quality Engineer Senior Quality Engineer Quality Assurance Manager
Quality Assurance Director
11 Yearsyrs
Quality Assurance Specialist Quality Assurance
Quality Assurance Manager
9 Yearsyrs
Validation Engineer Quality Engineer
Quality Manager
11 Yearsyrs
Senior Consultant Development Manager Quality Assurance Manager
Quality Program Manager
9 Yearsyrs
Quality Assurance Quality Assurance Lead Quality Assurance Manager
Quality Systems Manager
12 Yearsyrs
Project Leader Quality Assurance Lead Quality Assurance Manager
Regulatory Affairs Manager
9 Yearsyrs
Validation Engineer Project Manager Program Manager
Senior Manager
10 Yearsyrs
Quality Assurance Engineer Engineering Manager Manufacturing Manager
Senior Manufacturing Manager
14 Yearsyrs
Quality Engineer Quality Assurance Manager
Senior Quality Assurance Manager
11 Yearsyrs
Quality Assurance Engineer Quality Engineer Quality Manager
Senior Quality Manager
12 Yearsyrs
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Validation Specialist Demographics

Gender

  • Male

    53.2%
  • Female

    43.5%
  • Unknown

    3.2%

Ethnicity

  • White

    59.7%
  • Hispanic or Latino

    27.0%
  • Asian

    10.3%
  • Unknown

    2.3%
  • Black or African American

    0.8%
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Languages Spoken

  • Spanish

    92.0%
  • Portuguese

    2.9%
  • French

    2.3%
  • German

    0.6%
  • Hindi

    0.6%
  • Hebrew

    0.6%
  • Thai

    0.6%
  • Tamil

    0.6%
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Validation Specialist Education

Validation Specialist

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Real Validation Specialist Salaries

Job Title Company Location Start Date Salary
Validation Specialist Alpha Consulting Corporation Plainsboro, NJ Nov 12, 2015 $139,829
Validation Specialist Allergan Sales, LLC Irvine, CA May 28, 2016 $108,346
Validation Specialist Techdata Service Company, LLC. King of Prussia, PA Sep 24, 2015 $96,000
Validation Specialist Techdata Service Company, LLC. King of Prussia, PA Apr 19, 2016 $96,000
Validation Specialist Biothermal Validation LLC Contracting Company Rocky Mount, NC Aug 17, 2014 $93,915
Validation Specialist Compli, Inc. Frederick, MD Jul 12, 2016 $93,600
Validation Specialist Armaan Biotech & It Consultants Inc. Nazareth, PA Jul 12, 2015 $91,828
Validation Specialist Armaan Biotech & It Consultants Inc. Rensselaer, NY Jul 12, 2015 $91,828
Validation Specialist Armaan Biotech & It Consultants Inc. Nazareth, PA Sep 09, 2015 $91,828
Validation Specialist Kremers Urban Pharmaceuticals Inc. Seymour, IN Dec 15, 2014 $87,000
Validation Specialist II Armaan Biotech & It Consultants, Inc. Nazareth, PA Oct 02, 2016 $85,467
Validation Specialist II Armaan Biotech & It Consultants, Inc. Nazareth, PA Nov 19, 2015 $85,467
Validation Specialist/Engineer Aumvis Pharmatec LLC Vienna, VA Sep 16, 2015 $77,064
Validation Specialist (LAB Analytical Instruments) Revereit LLC Redwood City, CA Jan 10, 2016 $76,843
Validation Specialist Foster Wheeler Biokinetics, Inc. Philadelphia, PA Dec 02, 2013 $76,315
Validation Specialist IBM India Private Limited Indianapolis, IN Jun 09, 2014 $75,554
Validation Specialist Quality Systems Professionals, LLC Frederick, MD Apr 12, 2015 $75,132
Validation Specialists Integrated Resources, Inc. Fort Washington, PA Jan 06, 2015 $75,132
Validation Specialist New York Blood Center Islandia, NY Aug 04, 2014 $75,000
Validation Specialist/Engineer Aumvis Pharmatec LLC San Diego, CA Nov 03, 2016 $67,766
Regulatory (CMC) and Validation Specialist New England It Associates, Inc. Franklin Lakes, NJ Aug 20, 2016 $67,434
Validation Specialist, Engineering Merck Sharp & Dohme Corp. Point, PA Aug 29, 2013 $67,330
Validation Specialist JM Pharma, LLC Melville, NY Sep 11, 2015 $67,014
Validation Specialist Revereit LLC Thousand Oaks, CA Aug 05, 2014 $66,784

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Top Skills for A Validation Specialist

ProceduresIq/Oq/PqEnsureComplianceLaboratoryEquipmentSummaryReportsFDAFacilityValidationActivitiesRegulatoryRequirementsTemperatureFinalReportsValidationDocumentsHvacProcessValidationProtocolsGMPIOQPLCCSVFreezersIncubators

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Top Validation Specialist Skills

  1. Procedures
  2. Iq/Oq/Pq
  3. Ensure Compliance
You can check out examples of real life uses of top skills on resumes here:
  • Developed test procedures to challenge the installation or modification of equipment.
  • Completed multiple HVAC equipment qualification (IQ/OQ/PQ) projects for a variety of clients in the US and Canada.
  • Conduct Periodic Assessments of the Equipment Qualifications to ensure compliance with the company's SOP and Guidelines.
  • Evaluated Computer and Laboratory equipment validations.
  • Developed and executed protocols and wrote Final/Executive Summary Reports for equipment cleaning qualifications according to plant and regulatory agency requirements.

Top Validation Specialist Employers

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