Validation Engineer

Opus Scientific Published: September 28, 2016
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Opus Scientific is recruiting for Validation Engineers for a Long Island based, fast growing biopharmaceutical company with a market presence in 100 countries. Join this exciting organization offering competitive salaries and an excellent benefit package!


  • Validation of automated systems, cleaning validation, and periodic assessment / revalidation activities
  • Executes the testing of configuration changes to the Process Automation System and process recipes in the Manufacturing Execution System
  • Supports validation work from change controls, shutdown/changeover activity, and revalidation programs
  • Duties may include internal compliance or efficiency improvement efforts within department
  • Demonstrated proficiency in oral communication and technical writing skills
  • Strong experience in project management
  • Develop, review and approve qualification and validation documents
  • Oversee Manufacturing, Quality Control, Facilities, IT and Materials Management involving validation activities.
  • Perform gap analysis on previously performed validation/qualifications, design and implement protocols to mitigate deficiencies in previous validation/qualifications when needed
  • Review equipment manuals, specifications, drawings and operational documents to ensure validation and qualification protocols and standard operating procedures are in-line with manufacturer’s specifications, operational procedures, calibration requirements and required maintenance.
  • Ensure change control procedures are followed, equipment and utility changes and provide adequate oversight and follow-up on validation deviations both in terms of content and CAPA.
  • Write and edit validation/qualification protocols and SOPs.
  • Assist with audits, explaining validation and qualification activities performed at the site.


  • BS in Engineer (chemical preferred).
  • Minimum of 5 years’ experience with biopharmaceutical / pharmaceutical industry in the areas of biopharmaceutical operations and cGMP
  • Previous experience in one or more of the following items is preferred:


    • Chamber validation (incubators, freezers, autoclaves)
    • Experience with cleaning validation
    • Experience with sterilization validation
  • Knowledge of a system life cycle validation techniques for automation software specification and development


  • Familiarity with SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment
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