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Occupation information - In brief...



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In Brief... Engineer - Validation

 Brief Description:

Completes or oversees all the calibration and testing of the various instruments and pieces of equipment used in the lab for measuring, weighing and processing raw and refined materials



The validation engineer is usually responsible for determining what equipment in the lab needs to be replaced or removed, and also may be responsible for completing the laboratory equipment budget, purchasing new equipment and even training others on the team in the proper use of the equipment. The validation engineer often works directly with contractors, suppliers and vendors to troubleshoot or install equipment with the lab or manufacturing plant.

The validation engineer is usually the team leader or supervisory for the validation technicians and lab employees. He or she may also be directly involved in the training and mentoring of new employees and team members with regards to equipment use and calibration. The validation engineer should have excellent communication skills, be a problem solver, and have good understanding of good laboratory practices (GLP) and good manufacturing practices (GMP).

The validation engineer should be well versed in proper documentation and data analysis as well as be an independent worker and able to meet reporting deadlines and guidelines.



Typical tasks undertaken in this profession: 20

»  

Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of production problems. 

»  

Prepare validation and performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, and other types of production. 

»  

Coordinate the implementation or scheduling of validation testing with affected departments and personnel. 

»  

Study product characteristics or customer requirements and confer with management to determine validation objectives and standards. 

»  

Create, populate, or maintain databases for tracking validation activities, test results, or validated systems. 

»  

Prepare, maintain, or review validation and compliance documentation such as engineering change notices, schematics, and protocols. 

»  

Resolve testing problems by modifying testing methods or revising test objectives and standards. 

»  

Prepare detailed reports and design statements based on results of validation and qualification tests or reviews of procedures and protocols. 

»  

Identify deviations from established product or process standards and provide recommendations for resolving deviations. 

»  

Direct validation activities such as protocol creation or testing. 


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Education
Most of these occupations require qualifications at NFQ Levels 7 or 8 (Ordinary / Honours Degrees) but some do not.

Related Experience
A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an engineer must complete four years of college and work for several years in engineering 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 accountants, sales managers, computer programmers, teachers, chemists, environmental engineers, criminal investigators, and financial analysts.


Qualifications required?

Level 8 Honours Bachelor Degree

Typical entry routes:

The minimum level of education for a validation engineer is a Bachelors degree in a science field and several years experience in the field of validation. Many validation technicians work towards their Bachelors or Masters degrees while employed by a lab so that upon graduation they have both their degree and work experience.

Depending on the type of equipment and facility the validation engineer should have a good mechanical understanding of laboratory equipment as well as a background in computers. Additional certification for calibration of equipment is often considered critical. Some pharmaceutical and biotechnology companies require additional training in Aseptic Processing Guidelines as well as GLP and GMP training.

Related courses

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Sectors related to this occupation:

This occupation is typically found in the sectors below. You can explore information relating to sectors by clicking on the titles below.

Medical Devices
Chemical, Biomedical & Pharmaceutical Sciences

Future Skills Requirements & Concerns

Current Labour Market Research highlights concerns in some occupations. These comments are presented here where available: [source: Forfas]

The February 2013 Forfás report on the Future Skills Requirements of the Manufacturing Sector to 2020 reports that a significant number of engineering firms have indicated a current and future skills shortage of Validation Engineers.


 
This occupation has been viewed 56877 times
 
1 Salary Information
Note: All salaries are in thousands of euros and refer to annual salaries.

Job Title
Validation Engineer
Salary Range*
30 - 80
Related Information:
Validation Engineer: 35 - 70
Validation Manager: 50 -80
Validation Technician: 30 - 45
Data Source(s):
Collins McNicholas / Hudson / Morgan McKinley / Brightwater

Last Updated: March, 2013
* The lower figures typically reflect starting salaries. Higher salaries are awarded to those with greater experience and responsibility. Positions in Dublin sometimes command higher salaries.

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