Responsible Engineer / Filling Expert For Our Aseptic Filling Line In Drug Product Manufacturing

FUJIFILM Biotechnologies Denmark

Hillerød, Denmark
Not specified; not specified; competitive compensa...
3 years experience as engineer in gmp environment
2-3 years experience in aseptic filling equipment
Knowledge of validation and risk assessment
The role involves assuming technical ownership of the aseptic filling equipment to achieve and maintain a validated state

Job Summary

  • The role involves assuming technical ownership of the aseptic filling equipment to achieve and maintain a validated state.
  • Candidates will act as an Aseptic Filling Subject Matter Expert during tech transfer projects and provide Level 2 technical support for operations.
  • The company offers a competitive compensation package, access to fitness facilities, and an attractive canteen in a rapidly growing organization.

Matching Summary

The role involves assuming technical ownership of the aseptic filling equipment to achieve and maintain a validated state.

Salary

Not specified; Not specified; Competitive compensation package including fitness access and canteen

Skills & Requirements

Must-have

  • 3 years experience as engineer in GMP environment
  • 2-3 years experience in Aseptic Filling equipment
  • Knowledge of Validation and Risk Assessment
  • Technical ownership of aseptic filling equipment
  • Experience with CQV and equipment performance monitoring

Nice-to-have

  • Knowledge of Annex 1, 15, ASTM E2500, ICH Q9
  • Quality By Design (QbD) knowledge appreciated
  • Structured approach and strong interpersonal skills
  • Solution oriented with positive attitude
  • Team effort over individual performance

Key Requirements

  • Minimum 3 years engineering experience in GMP
  • 2-3 years specific Aseptic Filling equipment experience
  • Professionally qualified engineer

Work Rights

Not specified

Tailored Resume

Cover Letter