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Become A Validation Specialist

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Working As A Validation Specialist

  • Evaluating Information to Determine Compliance with Standards
  • Communicating with Supervisors, Peers, or Subordinates
  • Getting Information
  • Analyzing Data or Information
  • Identifying Objects, Actions, and Events
  • Deal with People

  • $86,000

    Average Salary

What Does A Validation Specialist Do At Kelly Services

* Supports projects by taking input from subject matter experts and converting that input into new or modified documents within the Quality System.
* Generates and executes documents including Standard Operating Procedures SOP s , Work Instructions WI s , Manufacturing Procedures, Work Instructions, User Requirement Specification, Factory Acceptance Testing, Device History Records DHR s , Product Development documents, Validation Protocols and Reports IQ/OQ/PQ/PV ,
* Trains or assists with the training of affected employees on any new or modified documents.
* Works closely with Manufacturing Process Engineers, Design Transfer Engineers, System Support Specialist, and other Operations Service management and support functions to ensure that all Operations needs are covered from a document change/implementation management standpoint.
* Works with Engineering, Quality, and Manufacturing personnel to solve process problems that prevent successful validation: Identifies problems, suggests approaches for corrective action, and evaluates the effectiveness of the corrective actions through documented studies.
* Serves as an active team member on key projects to ensure rapid conversion of ideas into action.
* Conducts validation activities to demonstrate that manufacturing processes can consistently produce results that meet pre-determined requirements.
* These projects can include new or modified processes

What Does A Validation Specialist Do At Catalent Pharma Solutions

* Draft protocols and reports for Computerized Systems Validation, and/or Automated Production Equipment Validation, and/or Facility Qualification, and/or Analytical Equipment Validation, and/or Process Validation and/or Cleaning Validation.
* Responsibilities include developing the appropriate and required protocol documents in accordance with the current site and corporate Validation SOP’s and guidelines.
* Obtaining approval signatures from the Catalent management and as required from customers.
* Execute approved protocols and coordinate the activities with other departments (e.g. engineering, maintenance, production, etc…) as required.
* Review and approve site Annual Product reviews.
* Assists in site NPIx gate reviews.
* Involvement with customer audits and responding to audit observations and corrective actions.
* Assist in investigations of manufacturing / facility deviations as asked of by Quality Systems.
* Addressing process/facility Change Controls issued.
* Addressing process/facility CAPAs issued.
* Interacts with customers, including participating in scheduled teleconferences and responding to customer requests/complaints.
* Candidate should have a relevant four-year college degree in the Engineering Field or Computer Sciences (e.g., Electrical, Mechanical, etc.) or relative life experience.
* Candidate must also have a minimum of five (5) years of validation experience.
* Supervisory experience is a plus

What Does A Validation Specialist Do At Arizona's Children Association

* Performs internal audits of medical records coding and billing
* Evaluates medical records and progress notes to ensure completeness, accuracy and compliant coding
* Runs internal reports and determines omissions, correctness errors, and measures timeliness of encounter submissions
* Validates encounter acceptance within the agency claims system
* Provides verbal and written technical assistance, training and education on medical coding to staff to improve accuracy of chart coding
* Investigates applicable critical incidents, internal complaints, formal grievances and prepares reports of findings
* Verifies CPT codes and follows internal procedures for submitting questions to clients before processing
* Adheres to all federal and agency-issued coding compliance laws, policies, and procedures
* Participates in coding review process to provide feedback
* Assists with the transition and implementation of any new coding, regulation and/or behavioral health billing policies and procedures, and communicates information and procedures to all relevant staff
* Monitors and evaluates the overall quality of behavioral health services provided by the agency to ensure compliance with contracts, licensing and regulations
* Must be able to safely and effectively monitor consumer activities, with or without a reasonable accommodation
* Performs other duties as assigned which are consistent with the general responsibilities of the position

What Does A Validation Specialist Do At Kforce

Review, recommend, and approve requirements specifications and verification methods, procedures, and results, which are communicated through requirement specifications, analysis, demonstration, inspection, test, and/or simulation results

What Does A Validation Specialist Do At Kelly Services

* Validate analytical test methods for drug products in compliance with company requirements and GMP guidelines
* Provide suggestions to improve existing methods
* Provide suggestions for corrections and clarifications
* Generate analytical method validation protocols and technical reports
* Develop stability study design and protocol writing and carry out stability studies

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Validation Specialist Career Paths

Validation Specialist
Validation Engineer Quality Engineer Quality Assurance Manager
Quality Assurance Director
11 Yearsyrs
Validation Engineer Quality Engineer Quality Manager
Quality Systems Manager
12 Yearsyrs
Consultant Project Manager Quality Manager
Corporate Quality Manager
12 Yearsyrs
Validation Engineer Quality Engineer Supplier Quality Engineer
Supplier Quality Manager
13 Yearsyrs
Consultant Supervisor Quality Assurance Manager
Regulatory Affairs Manager
8 Yearsyrs
Quality Assurance Specialist Quality Assurance Manager Quality Manager
Project Quality Manager
10 Yearsyrs
Consultant Owner/Operator Construction Manager
Capital Project Manager
10 Yearsyrs
Project Manager Owner/Operator Construction Manager
Commissioning Manager
11 Yearsyrs
Senior Validation Specialist Senior Validation Engineer
Validation Manager
10 Yearsyrs
Quality Assurance Specialist Quality Assurance Engineer Senior Quality Engineer
Quality Program Manager
10 Yearsyrs
Process Engineer Project Engineer Project Lead Engineer
Lead Engineer And Project Manager
7 Yearsyrs
Quality Assurance Specialist Quality Assurance Engineer Supplier Quality Engineer
Assistant Manager Of Quality
6 Yearsyrs
Compliance Specialist Regulatory Specialist Regulatory Affairs Manager
Regulatory Compliance Director
12 Yearsyrs
Project Leader Manager Applications Development Data Manager
Clinical Study Manager
9 Yearsyrs
Senior Scientist Research Manager Clinical Research Manager
Clinical Trial Manager
10 Yearsyrs
Project Manager Information Technology Project Manager Engineering Program Manager
Account And Program Manager
8 Yearsyrs
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Validation Specialist Demographics

Gender

Male

50.5%

Female

42.1%

Unknown

7.4%
Ethnicity

White

51.8%

Hispanic or Latino

26.4%

Asian

10.4%

Black or African American

8.0%

Unknown

3.3%
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Foreign Languages Spoken

Spanish

91.6%

Portuguese

3.1%

French

2.1%

German

0.5%

Carrier

0.5%

Hindi

0.5%

Hebrew

0.5%

Thai

0.5%

Tamil

0.5%
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Validation Specialist Education

Schools

University of Puerto Rico - Mayaguez

26.1%

University of Phoenix

13.6%

Stevens Institute of Technology

9.0%

New Jersey Institute of Technology

5.2%

University of Puerto Rico - Humacao

4.9%

Sistema Universitario Ana G Mendez - Universidad Del Turabo

4.1%

Pontifical Catholic University of Puerto Rico

4.1%

North Carolina State University

3.8%

University of Pittsburgh -

3.3%

Temple University

3.0%

University of Puerto Rico - Cayey

3.0%

Pennsylvania State University

2.7%

Northeastern University

2.7%

Strayer University

2.7%

Purdue University

2.4%

University of Puerto Rico - Arecibo

2.2%

University of Puerto Rico - Medical Sciences Campus

2.2%

Drexel University

1.9%

Universidad Politecnica de Puerto Rico

1.6%

Michigan State University

1.6%
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Majors

Business

13.8%

Chemistry

11.5%

Biology

11.4%

Chemical Engineering

9.6%

Mechanical Engineering

7.9%

Electrical Engineering

6.2%

Pharmacy

5.7%

Industrial Engineering

4.5%

Computer Science

3.8%

Management

3.5%

Microbiology

3.3%

Biotechnology

2.8%

Engineering And Industrial Management

2.3%

Computer Information Systems

2.3%

Accounting

2.3%

Biochemistry, Biophysics, Molecular Biology

2.1%

Health Care Administration

1.9%

Manufacturing Engineering

1.7%

Psychology

1.7%

Environmental Control Technologies/Technicians

1.7%
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Degrees

Bachelors

52.8%

Masters

23.6%

Other

11.6%

Associate

5.8%

Certificate

3.1%

Doctorate

2.2%

Diploma

0.8%

License

0.2%
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Job type you want
Full Time
Part Time
Internship
Temporary
Average Yearly Salary
$86,000
View Detailed Salary Report
$57,000
Min 10%
$86,000
Median 50%
$86,000
Median 50%
$86,000
Median 50%
$86,000
Median 50%
$86,000
Median 50%
$86,000
Median 50%
$86,000
Median 50%
$129,000
Max 90%
Best Paying Company
Allied Solutions
Highest Paying City
San Mateo, CA
Highest Paying State
Alaska
Avg Experience Level
2.3 years
How much does a Validation Specialist make at top companies?
The national average salary for a Validation Specialist in the United States is $86,379 per year or $42 per hour. Those in the bottom 10 percent make under $57,000 a year, and the top 10 percent make over $129,000.

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 Specialists Integrated Resources, Inc. Fort Washington, PA Jan 06, 2015 $75,132
Validation Specialist Quality Systems Professionals, LLC Frederick, MD Apr 12, 2015 $75,132
Validation Specialist Halo Pharmaceutical, Inc. NJ Dec 09, 2016 $75,000
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
Cleaning Validation Specialist Revereit LLC Lakewood, NJ Oct 01, 2015 $66,784
Validation Specialist (Software & Instruments) Revereit LLC Berkeley, CA Jul 15, 2015 $66,784

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Top Skills for A Validation Specialist

  1. Validation Protocols
  2. Procedures
  3. Ensure Compliance
You can check out examples of real life uses of top skills on resumes here:
  • Review, track and file of departmental documentation, such as executed software/system development life cycle documents and executed qualification/validation protocols.
  • Developed standards and procedures for documentation control and quality assurance and of solid dosage forms.
  • Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
  • Develop IQ/OQ/PQ Protocols for manufacturing equipment, utilities and facilities used in drug product manufacturing.
  • Obtained data and generated the necessary documentation to incorporate laboratory equipment in the Calibration and Preventive Maintenance program.

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Top 10 Best States for Validation Specialists

  1. District of Columbia
  2. Alaska
  3. Virginia
  4. Idaho
  5. Maryland
  6. Pennsylvania
  7. Alabama
  8. Minnesota
  9. Massachusetts
  10. New Jersey
  • (79 jobs)
  • (20 jobs)
  • (354 jobs)
  • (36 jobs)
  • (185 jobs)
  • (366 jobs)
  • (88 jobs)
  • (253 jobs)
  • (359 jobs)
  • (286 jobs)

Top Validation Specialist Employers

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