Senior Validation Engineer

1 month ago


Devens, Massachusetts, United States Omni Inclusive Full time
Job Title: Senior Validation Engineer

Omni Inclusive is seeking a highly skilled Senior Validation Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the accuracy and reliability of our equipment and software.

Responsibilities:
  • Lead the qualification of QC equipment and its associated software, ensuring compliance with regulatory requirements.
  • Design, execute, and manage QC instrument/software qualification documents, including user requirement specifications, design qualification, validation plans, and equipment IOQ protocols.
  • Author and execute computer system validation scripts using electronic validation databases or paper-based methods.
  • Own change controls specific to the qualification of QC instruments and its associated software.
  • Update the asset management database to reflect new assets, calibrations, and preventative maintenances.
  • Author instrument operational SOPs as needed.
  • Coordinate and interface with vendors on site.
  • Champion qualification deviations and software defects, identifying root causes and corrective actions.
  • Act as a liaison between Digital Plant (IT) and lab departments.
  • Execute periodic assessments and decommissioning, as needed.
Qualifications and Experience:
  • Bachelor's degree in a relevant scientific, engineering, or computer-based area, with a minimum of 5 years' experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.
  • Quality management system experience, including document control, change controls, investigations, deviations, electronic validation databases, and asset management database.
  • Knowledge of cGMP regulatory requirements, computerized analytical systems, and electronic record/electronic signature, data integrity, and disaster recovery.
  • Demonstrated experience in solving complex technical issues and troubleshooting process defects.
  • Strong communication and collaboration skills, with the ability to influence cross-functional teams.
  • Working knowledge of laboratory systems, including Empower, NuGenesis, and other software programs, including Microsoft Office Applications.
  • Must have computer system validation experience, equipment validation experience, and GMP experience.


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