Validation Specialist


Prepare and execute Computer Validation, equipment qualification plans and protocols. Write Final Summary Reports that summarize executed qualifications/validations. Assist in the development, coordination and execution of qualifications/validation protocols for systems governed by federal regulations as applicable in the pharmaceutical industry. Coordinate validation related activities in regards to equipment and processes being deployed in GMP environments.


  • Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations.
  • Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable).
  • Develop and execute cleaning validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment.
  • Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water and surface swabbing for testing as outlined by validation/qualification protocols.
  • Perform physical testing from representative samples.
  • Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
  • Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
  • Draw conclusions from data, observations, deviation/exception and investigation as to whether process is considered valid.
  • Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
  • Ensure protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are stored according to procedure.
  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.


  • Knowledge of FDA regulated biotechnology or drug validation requirements including knowledge of FDA 21 CFR Parts 210 and 211.
  • Knowledge of Analytical Balance, LOD Instrument, Micrometer, Friabilator, Hardness Tester, Calculator, Particle Size Analyzer, Disintegration Apparatus, Viscometer.
  • Knowledge of Statistical software and calculations.
  • Knowledge of manufacturing processes, sampling techniques, government regulations and guidelines pertaining to those areas.
  • Knowledge of SCADA control system.
  • Strong understanding of cGMPs and validation/qualification concepts.
  • Ability to read, program, troubleshoot PLC Ladder Logic and HMI software.
  • Ability to analyze pharmaceutical processes to determine critical parameters and critical quality attributes and design testing in the form of protocols to ensure robust and repeatable process. Must have in-depth knowledge of equipment set-up and operation, facility qualifications, master validation policies and protocol generation, and protocol execution.


  • Bachelor's degree in Chemistry, Pharmacy, Engineering or related Science; or equivalent combination of
  • Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
  • Three years' proven experience in validation, with particular knowledge of 21 CFR Part 210 and 211.

Experience in 21 CFR Part 11 desired.

Job Type: Full-time

Salary: $30.00 to $37.00 /hour


  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
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