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Validation Engineer

  • Location: Massachusetts
  • Job Type:Contract

Posted 8 months ago

  • Expiry Date: 12 February 2023
  • Referral:

Job Description:

Responsibilities will include (but not limited to):

  • Qualify QC equipment.

  • Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, risk assessments, qualification summary reports.

  • 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.

  • Assist with onboarding/relocating instruments.

  • Decommission equipment as needed.

  • Coordinate/interface/host vendors on site.

  • Champions qualification deviations, identifying root causes and Corrective Actions/Preventive Actions (CA/PAs).

  • Acts as the liaison between Digital Plant (IT) and lab departments.

Qualifications and Experience Required:

  • Bachelor’s degree in relevant scientific, engineering, or computer-based area with a minimum of 4 years experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.

  • Quality management system experience that includes document control/management, change controls, investigations, deviations, asset management database.

  • Knowledge of cGMP regulatory requirements, Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects.

  • Demonstrated success in cross functional influencing, strong communication, and collaboration skills

  • Must have equipment validation experience.

  • Must have GMP experience.

  • Must have change control experience.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.