Pharmaceutical Validation Job Profile and Description

A pharmaceutical validation specialist is mainly responsible for planning, scheduling, executing and leading various validation project assignments. The validation assignments include designing, development, validation, qualification and implementation of both the existing and new facilities, products, utilities, equipment, processes, instrumentation systems etc. The pharmaceutical validation specialist is responsible for leading cross-functional project teams in the devising, implementation and development of validation plans and protocols.

Pharmaceutical Validation Duties and Responsibilities

Typical duties that a pharmaceutical validation representative has to perform include the following:

  • Arranging, planning, managing and executing installations, operations and performance qualifications of packaging, laboratory and utility systems.
  • Scheduling, planning, managing and executing studies for clean validation.
  • Scheduling, planning, managing and executing process validation studies and authoring related plans, summary reports and protocols.
  • Reviewing and approving validation project documentation.
  • Coordinating and interfacing with the process unit heads, quality and engineering groups for assuring successful project execution.
  • Leading and coordinating cross-functional teams for project validation.
  • Prioritizing, managing and executing multiple projects utilizing the project management methodologies.
  • Overseeing external validation resources that could be useful.
  • Supporting the development of best and proven validation practices in the validation department, based upon current industry guidelines and practices.
  • Authoring relevant standard operating procedures for ensuring compliance with the company’s policies.
  • Supporting regulatory submissions and also regulatory agency inspections whenever required.
  • Championing continuous improvements in the validation department.

Pharmaceutical Validation Skills and Specifications

Some of the core skills expected from a pharmaceutical validation specialist are as follows:

  • Excellent leadership and managerial skills.
  • Must be well organized.
  • Superb communication and interpersonal skills for coordinating between the various departments and staff of the company as well as the validation cell.
  • Must be well organized with good oral and written skills besides giving attention to details.
  • Knowledge of the various state and federal pharmaceutical validation laws and legislations that are enforced from time to time.

Pharmaceutical Validation Education and Qualification

Following are the education and qualifications required for being a pharmaceutical validation specialist.

  • Bachelors’ degree in life sciences or engineering or relevant fields.
  • At least 4-5 years experience in a highly regulated environment like biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements.
  • Experience in project management.

Pharmaceutical Validation Salary

A pharmaceutical validation specialist can draw a salary of about $55,150 per year which will also increase as the experience of the candidate increases.