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Bioscience Careers

Validation specialists

  • Produced by the North Carolina Association for Biomedical Research (NCABR)
  • Funding generously provided by the Biogen Idec Foundation

Pharmaceutical manufacturing facilities and laboratories are equipped with a variety of testing equipment vital everyday operations. Validation specialists, also called validation or testing technicians, act as equipment auditors by inspecting, confirming and documenting that their organization’s equipment is in working order.

The tests that validation specialists perform ensure that a pharmaceutical product is manufactured according to various regulations, organization guidelines and industry standards. Validation specialists meticulously record all testing data before analyzing it. This information then is used to prepare regular reports to management. In some organizations, specialists prepare and present weekly reports to management on their findings.

In addition to excellent written and oral communication skills, knowledge of spreadsheet and word processing software is required. While much of the specialist’s work is routine in nature, specialists also work as investigators by offering reasons for validation failures in their weekly reports.

Career Opportunities

Validation specialists work alongside other specialists in most organizations, under direct supervision. With experience, specialists may become intimately familiar with the standard concepts, practices and procedures in their field and develop strong troubleshooting capabilities. Individuals in these cases may advance to supervisory positions or to a related position such as a validation engineer. In some cases, validation engineers may serve as the department manager. Validation specialists with a high school diploma may need to complete a bachelor’s degree in a science-related major to advance into this position.

Education/Training

Most entry level positions require a bachelor’s degree. However, individuals with an associate’s degree and two to three years of work experience, or a high school diploma and four to five years of work experience, also may be qualified for these positions. While it is useful to know industry guidelines and organizational practices, most organizations offer on-the-job training in specific procedures.

Salary

The general entry-level salary range for a validation specialist is $40,000 to $50,000 per year. Salary information is current as of April 2010.