Senior Process Engineer - GMP Biotech Process Innovation

7266-Janssen Biologics B.V. Legal Entity; Amsterdam; On-site; EUR 53,500 - 85,445; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well‑being reimbursement programs

Service anniversary and recognition

Job summary

Johnson & Johnson in Leiden, Netherlands, seeks a Senior Process Engineer to lead the introduction and implementation of new production processes and technologies for commercial manufacturing and product supply.

You will optimize DSP operations, own process control and validation to stay within validated limits, and drive data analysis to identify trends and continuous improvement opportunities. Collaboration across Operations, Quality, Engineering, and MSAT is essential.

Qualifications

• Master’s or PhD in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, Life Sciences, or related field.
• Approximately 6–8 years of GMP pharmaceutical/biotech manufacturing experience with strong DSP exposure.
• Proven experience supporting commercial manufacturing, investigations, change controls and continuous improvement.
• Fluent in English; Dutch proficiency preferred.

Responsibilities

• Lead introduction and implementation of new production processes and technologies for commercial manufacturing.
• Optimize downstream processing (DSP) operations to improve yield, reliability, and uptime.
• Own process control and validation activities within validated and regulatory limits.
• Drive data collection, analysis and reporting to identify trends and root causes.
• Initiate and manage Product Impact Assessments and Change Controls with cross‑functional teams.
• Perform Gemba walks and support inspections and audits for continuous improvement.

Skills

Analytical Reasoning

Process Engineering

Process Control

Gemba Kaizen

Problem Solving

Data Analysis

Team Collaboration

Education

Master’s or PhD in Biotechnology or related field

Tools

Validation Testing

Computerized Equipment Skills

Job description

Johnson & Johnson in Leiden, Netherlands, seeks a Senior Process Engineer to lead the introduction and implementation of new production processes and technologies for commercial manufacturing and product supply.

You will optimize DSP operations, own process control and validation to stay within validated limits, and drive data analysis to identify trends and continuous improvement opportunities. Collaboration across Operations, Quality, Engineering, and MSAT is essential.