Responsible Engineer (Pharmaceutical, Hillerød)

Job summary

This role involves taking technical ownership of aseptic filling equipment within a Drug Product Manufacturing Facility, contributing significantly to operational and tactical levels. The position is crucial for maintaining the validated state of the filling line and enhancing equipment performance.

Qualifications

• Minimum of 3 years of engineering experience in a GMP environment.
• 2-3 years of experience specifically with aseptic filling equipment is required.
• Familiarity with validation and risk assessment of manufacturing equipment in a GMP context.
• Knowledge of relevant regulations and guidelines such as Annex 1, 15, ASTM E2500, ICH Q9, and Quality By Design is appreciated.

Responsibilities

• Assume technical ownership of filling equipment post-system release activities.
• Develop and maintain documentation for equipment and processes.
• Create a strategy for filling format parts and develop operational procedures for handling them.
• Monitor equipment performance through periodic reviews and drive improvement projects.
• Provide support for tech transfer programs and operations as the equipment owner.
• Manage GMP events related to equipment, including deviations and change controls.
• Participate in operational board meetings and validation activities, offering technical support for GMP events.
• Act as second-line support for filling equipment and process issues, leading troubleshooting efforts.

Skills

• Strong interpersonal skills and a structured approach to problem-solving.
• Ability to work collaboratively and value team efforts.
• Solution-oriented mindset with a positive attitude towards challenges.

Education

• Relevant engineering degree or equivalent experience in a related field.

Tools

• Familiarity with GMP-compliant manufacturing tools and methodologies.