Deviation Investigator (1-Year Assignment) for our Deviation Investigation Team

FUJIFILM Biotechnologies; Hillerød; Híbrido; DKK 700.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work 1 day/week

Descripción de la vacante

FUJIFILM Biotechnologies in Denmark is seeking a motivated Deviation Investigator for the DP/FG Deviation Investigation Team on a 1-year assignment. You will drive systematic problem solving, coordinate cross-functional investigations, and ensure GMP compliance across operations, QA, engineering, and validation.

The role requires a structured, analytical mindset with strong communication and stakeholder management skills, and a proactive approach to CAPAs and process improvements.

Formación

• Bachelor’s or Master’s degree in Engineering, Science, Pharmacy, Biotechnology, or a related discipline.
• Experience working in a GMP-regulated manufacturing environment is preferred.
• Experience with deviation investigations, root cause analysis, and quality systems is an advantage.

Responsabilidades

• Lead and facilitate deviation investigations to closure.
• Ensure deviations progress according to agreed timelines and quality standards.
• Coordinate investigation activities with SMEs and stakeholders across Operations, QA, Engineering, Validation, and other supporting functions.
• Drive structured root cause analysis using systematic problem-solving methodologies.
• Collect, analyze, and document investigation data and evidence.
• Support determination of corrective and preventive actions (CAPAs).
• Prepare clear, concise, and GMP-compliant investigation documentation.
• Contribute to continuous improvement of investigation processes and problem-solving practices

Conocimientos

Problem-solving

Communication

Stakeholder management

Self-driven

Analytical thinking

Educación

Bachelor’s or Master’s degree in Engineering, Science, Pharmacy, Biotechnology, or related

Descripción del empleo

We are looking for a motivated and structured Deviation Investigator to join the Drug Product (DP) / Finished Goods (FG) Deviation Investigation Team for a 1-year assignment.

As a Deviation Investigator, you will play a key role in driving systematic problem solving, coordinating cross-functional investigations, and ensuring compliance with GMP and quality requirements.

Key responsibilities

• Lead and facilitate deviation investigations to closure.
• Ensure deviations progress according to agreed timelines and quality standards.
• Coordinate investigation activities with SMEs and stakeholders across Operations, QA, Engineering, Validation, and other supporting functions.
• Drive structured root cause analysis using systematic problem-solving methodologies.
• Collect, analyze, and document investigation data and evidence.
• Support determination of corrective and preventive actions (CAPAs)
• Prepare clear, concise, and GMP-compliant investigation documentation.
• Contribute to continuous improvement of investigation processes and problem-solving practices

Qualifications

Professionally

• Bachelor’s or Master’s degree in Engineering, Science, Pharmacy, Biotechnology, or a related discipline.
• Experience working in a GMP-regulated manufacturing environment is preferred.
• Experience with deviation investigations, root cause analysis, and quality systems is an advantage.

Personally

• Strong systematic and analytical problem-solving skills.
• Ability to manage multiple investigations and priorities simultaneously.
• Structured and detail-oriented approach to work.
• Strong facilitator and stakeholder management skills.
• Self-driven with a proactive mindset.
• Excellent communication and collaboration skills.
• Ability to maintain momentum and ensure progress across multiple ongoing activities.
• Comfortable working in a fast-paced manufacturing environment.

About the department and the team

The Operational Excellence DP/FG department drives process optimization and quality enhancement within our fast-paced production facility. The department is structured into three core functional areas to ensure seamless execution and sustainable growth covering:

• Deviation Handling
• Project & Portfolio Management
• Continuous Improvements & General Business Support.

You will be part of the OpEx Group, which consists of 10 highly skilled individuals. Additionally, the department also manages all student workers and interns, creating a vibrant, energetic environment.

The actual investigation team consists of 4-5 investigators responsible for facilitating deviation investigations and ensuring timely progression and closure of deviations across manufacturing operations.

We foster an open, friendly, and relaxed culture with a good sense of humor. We have fun together and prioritize each person’s optimal work–life balance. Remote work is available one day per week, depending on task and program needs.

What we offer

• An opportunity to be part of a highly engaged team of experienced investigators.
• Exposure to complex manufacturing processes and cross-functional problem solving.
• A dynamic environment where you can make a direct impact on quality, compliance, and operational performance.
• Development of investigation, facilitation, and leadership competencies within a GMP manufacturing setting.

Working at FUJIFILM Biotechnologies

We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.

FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

We offer the chance to be part of a global workplace where passion, drive, and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.