Validation Engineer

Curium

Noblesville, IN, United States
On-site
Gmp manufacturing and qc laboratory systems
Cleaning validation and facility
Equipment, and system qualification
The Validation Engineer is responsible for driving compliance, supporting validation projects and establishing risk-based validation strategy to enhance efficiency, regulatory, compliance and operational excellence including Data Integrity for GMP manufacturing and QC Laboratory systems at multi facilities of Curium located in North America

Job Summary

  • The Validation Engineer is responsible for driving compliance, supporting validation projects and establishing risk-based validation strategy to enhance efficiency, regulatory, compliance and operational excellence including Data Integrity for GMP manufacturing and QC Laboratory systems at multi facilities of Curium located in North America.
  • The candidate will support the execution of validation activities for one or more of the following areas: Cleaning Validation and Facility, Utility, Equipment, and System Qualification.
  • Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, policies and procedures.

Matching Summary

The Validation Engineer is responsible for driving compliance, supporting validation projects and establishing risk-based validation strategy to enhance efficiency, regulatory, compliance and operational excellence including Data Integrity for GMP manufacturing and QC Laboratory systems at multi facilities of Curium located in North America.

Skills & Requirements

Must-have

  • GMP manufacturing and QC Laboratory systems
  • Cleaning Validation and Facility
  • Equipment, and System Qualification
  • Validation life cycle activities
  • Kaye Validator, ValProbe, or Ellab equipment
  • Global cGMPs and Validation Life Cycle

Nice-to-have

  • Radiopharmaceutical processing familiarity
  • Results-oriented and decision making
  • Team-based environment participation

Key Requirements

  • Bachelors Degree in related life sciences or Engineering
  • Three (3) or more years of relevant experience
  • Minimum of two (2) years of validation experience with sterile processes
  • Working knowledge of global cGMPs (to include EU standards)
  • Familiarity with the Sterile manufacturing and packaging facilities

Work Rights

Not specified

Tailored Resume

Cover Letter