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

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

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

• Profesionally

• 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.