QC Instrument Engineer: GMP Automation & Qualification

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 650,000 - 850,000; Full time

Benefits offered by this job

Competitive salaries

Bonuses

Health insurance

Wellness options

Fitness center

Social club events

Flexible working

Canteen and Friday breakfasts

Job summary

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS in Hillerød is seeking a qualification professional to coordinate instrument and software qualification across labs and manufacturing units, ensuring cGMP compliance and data integrity.

You will drive improvements, support end-users, and collaborate with stakeholders in a fast-paced, international environment, contributing to the QC/Manufacturing team’s goals and embracing new technologies.

Qualifications

• Passion for implementing instruments and technology with a user-benefit focus, understanding the crucial role of teamwork.
• Ability to juggle tasks and adapt to changing priorities in a dynamic GMP environment.
• Excellent communication and collaboration skills for achieving stakeholder buy-in.
• Experience in instrument/equipment qualification, maintenance, data integrity, and support functions.
• IT skills are advantageous but not required.
• More than 3 years of experience in cGMP and pharmaceutical manufacturing.
• Fluent English proficiency as we operate internationally.

Responsibilities

• Coordinate and perform instrument and software qualification across diverse labs and manufacturing units.
• Identify and implement solutions that boost compliance, integration, automation, and empower end-users.
• Deliver exceptional support to stakeholders within a cohesive team that makes the most of each member's strengths.
• Drive and support projects, collaborating closely with stakeholders.
• Ensure instrument systems and documentation adhere to cGMP and Data Integrity standards.
• Use your expertise to innovate and champion continuous improvement within the team.

Skills

Instrument qualification

Data integrity

Collaboration

GMP experience

English fluency

Education

Bachelor's degree or equivalent

Job description

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS in Hillerød is seeking a qualification professional to coordinate instrument and software qualification across labs and manufacturing units, ensuring cGMP compliance and data integrity.

You will drive improvements, support end-users, and collaborate with stakeholders in a fast-paced, international environment, contributing to the QC/Manufacturing team’s goals and embracing new technologies.