Validation Engineer

Validation Engineer (Pharma)
Rockville, MD 20850
Full-time
 

PURPOSE OF JOB ROLE:

The primary responsibility is to support the qualification of GxP systems across the company's manufacturing and laboratory areas. Assure the validation program is compliant with global, site and industry practices.

KEY RESPONSIBILITIES: 

  • Supports system qualification/validation and projects by writing and executing validation protocols ensuring compliance with cGMPs.
  • Will support one or more of the following disciplines:
    • Facility and Utilities, Process Equipment, Analytical Instrument, Cleaning Process or Computerized Systems
  • Authors final reports summarizing execution validation/qualification protocols and support documents (amendments, repeat test forms, addenda and deviations).
  • Interface with Validation, Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
  • Schedule and coordinate validation activities with system owners and key stakeholders.
  • Participate in change control reviews.
  • Responsible for continuous improvement of validation programs.
  • Participates in site projects and initiatives as necessary.
  • Trained self inspections and participate in >25% of department’s self Inspections.
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Company
Yoh
Posted
09/12/2021
Type
Full time
Location
Rockville, MD 20849, US