Senior Process Engineer

Senior Process Engineer – Leiden, South Holland, Netherlands

Job Description
You will help ensure reliable commercial manufacturing of biologic medicines by implementing new processes, optimizing downstream operations, and supporting cross‑functional teams to keep quality, safety, and compliance at the highest level.

Responsibilities

Lead the introduction and implementation of new production processes and technologies to support commercial manufacturing and product supply.

Optimize downstream processing (DSP) operations to improve yield, reliability, and minimize downtime.

Own process control and validation activities, ensuring processes run within validated and regulatory limits and that process records remain compliant.

Drive data collection, analysis, and reporting to identify trends, root causes, and opportunities for continuous process improvement and CPV actions.

Initiate, design, and manage Product Impact Assessments and Change Controls from initiation to completion, coordinating with Operations, Quality, Engineering, MSAT, and Digital.

Perform Gemba walks and act as a subject‑matter expert for inspections and audits, leading sustainable improvements in safety, quality, cost, and schedule.

Qualifications

Master’s or PhD in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, Life Sciences, or a related discipline.

Approximately 6–8 years’ relevant experience in GMP pharmaceutical or biotechnology manufacturing, with strong operational DSP experience.

Proven experience supporting commercial manufacturing, investigations, change controls, and continuous improvement initiatives.

Comfortable working in multidisciplinary operational environments and collaborating across functions.

Fluent in English (required); proficiency in Dutch is preferable.

Strong analytical thinker who handles complexity, uses data to find root causes, stays calm under pressure, and adapts to changing priorities.

Preferred Skills

Analytical Reasoning

Computerized Equipment Skills

Emerging Technologies

Gemba Kaizen

Issue Escalation

Lean Supply Chain Management

Problem Solving

Process Control

Process Engineering

Process Oriented

Product Improvements

Science, Technology, Engineering, and Math (STEM) Application

Situational Awareness

Supply Planning

Technical Research

Technologically Savvy

Validation Testing

Pay Range
€53,500.00 – €85,445.00

Benefits
In addition to base pay, we offer an annual bonus with a target percentage of pay based on performance, vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, and programs for financial, physical, and mental health. Other benefits include service‑anniversary and recognition awards, and participation in various insurance plans for eligible employees and dependents.

For more information, visit the employee benefits page.

Equal Opportunity Statement
Johnson & Johnson is an equal opportunity employer. We encourage diversity and inclusion in all aspects of employment.

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