Senior Validation Specialist

5 days ago


Devens, Massachusetts, United States Omni Inclusive Full time

Job Overview

Omni Inclusive is seeking a highly skilled Senior Validation Specialist to join our team in Devens, MA. This hybrid role involves 4 days onsite and 1 day remote work. As the project lead for qualification of QC equipment and software, you will be responsible for designing, executing, managing, and implementing qualification documents.

Responsibilities

  • Lead projects for qualification of QC equipment and software
  • Design, execute, manage, and implement qualification documents
  • AUTHOR/EXECUTE COMPUTER SYSTEM VALIDATION SCRIPTS
  • OWN CHANGE CONTROLS SPECIFIC TO THE QUALIFICATION OF QC INSTRUMENTS AND ITS ASSOCIATED SOFTWARE
  • UPDATE THE ASSET MANAGEMENT DATABASE TO REFLECT NEW ASSETS, CALIBRATIONS, PREVENTATIVE MAINTENANCES
  • AUTHOR INSTRUMENT OPERATIONAL SOPs AS NEEDED
  • COORDINATE/INTERFACE/HOST VENDORS ON SITE
  • CHAMPION QUALIFICATION DEVIATIONS/SOFTWARE DEFECTS, IDENTIFYING ROOT CAUSES AND CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CA/CLIENT)
  • ACTION AS THE LIAISON BETWEEN DIGITAL PLANT (IT) AND LAB DEPARTMENTS
  • COMPLETE DECOMMISSIONING/PERIODIC ASSESSMENTS

Required Skills and Qualifications

  • Bachelor's degree in a relevant scientific, engineering, or computer-based area with 6-10+ years experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.
  • Quality management system experience including document control/management, change controls, investigations, deviations, electronic validation databases, asset management database.
  • Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery.
  • Demonstrated success in cross-functional influencing, strong communication, and collaboration skills.
  • Working knowledge of laboratory systems such as Empower, NuGenesis and other software programs, including Microsoft Office Applications, preferred.
  • MUST HAVE EQUIPMENT VALIDATION EXPERIENCE
  • MUST HAVE GMP EXPERIENCE
  • MUST HAVE QUALITY MANAGEMENT SYSTEM (QMS) EXPERIENCE
  • EXPERIENCE IN COMPUTER SYSTEM VALIDATION IS A PLUS.
  • EXPERIENCE IN ANY ASSET MANAGEMENT SOFTWARE IS A PLUS.

Estimated Salary: $120,000 - $150,000 per year



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