Quality Control Engineer

Job Title: QC Instrument Engineer

Location: Hillerød

About the Role

We are seeking a highly motivated QC Instrument Engineer to join our team and take a leading role in the qualification and lifecycle management of analytical equipment and instrument systems within Quality Control (QC). This position offers a unique opportunity to work across departments, ensuring compliance, efficiency, and data integrity throughout the equipment lifecycle.

Key Responsibilities

As QC Instrument Engineer, you will:

• Lead the qualification efforts for QC analytical equipment and instrument systems.
• Provide project management oversight for qualification, validation, decommissioning, and integration of instruments with computer systems.
• Support system administration during validation and act as backup system administrator once systems are in production use.
• Coordinate projects and deliverables, ensuring alignment with FDBD policies and procedures.
• Write, review, and maintain technical documentation, including protocols and system administration procedures.
• Manage equipment/instrument availability, prioritize tasks, and ensure adherence to regulatory requirements.
• Collaborate closely with Quality, IT, Validation, Metrology, and external vendors.

Key Requirements

• Minimum 3 years of experience in a related role, preferably within a regulated pharmaceutical environment.
• Strong understanding of cGMP and Data Integrity principles.
• Experience with QC instrumentation and system qualification/validation.
• Ability to manage multiple projects and interface effectively across departments.
• Strong written and verbal communication skills.

Educational Background

• Bachelor's degree (or higher) in Life Sciences, Engineering, or IT.
• Fluency in English is required; proficiency in Danish is a plus.
• Project Management certification is an advantage.

Preferred Qualifications

• Pharmaceutical industry experience.
• Familiarity with current industry trends and alignment with business needs.