Senior Cleaning Process Engineer – API Manufacturing

Cari; København; Hybrid; DKK 652,000 - 957,000; Full time

Job summary

Cari in Kalundborg, Denmark is seeking a Senior Process Engineer, Cleaning to maintain and improve pharmaceutical cleaning processes. You will use data and process understanding to sustain validated operations and support continuous improvement, ensuring product quality for patients.

This role requires deep GMP knowledge, 6+ years in pharma cleaning, and ability to drive investigations, validation activities and cross-functional collaboration in a global manufacturing setting.

Qualifications

• Bachelor’s or Master’s degree in a relevant scientific or technical field.
• 6+ years of experience with cleaning in pharmaceutical or API manufacturing.
• Independent understanding of cleaning principles and how chemistry and equipment interact.
• Experience with cleaning validation and process optimisation.
• Strong GMP knowledge and good documentation practices (cGMP).
• Ability to monitor data, derive insights and propose actionable alternatives.
• Ability to explain complex information to different audiences; good stakeholder engagement.
• Quality mindset, teamwork and independent decision-making.

Responsibilities

• Support daily process execution and troubleshooting; use systematic problem solving to identify root causes and drive improvement.
• Use data to visualise, analyse and explain process performance; standardise data collection and analysis.
• Develop scientific understanding of the process and link to product quality; justify optimisation projects.
• Develop and perform process confirmation; grow responsibility for cleaning validation and other qualification/validation activities.
• Develop colleagues into subject matter experts and maintain ongoing development plans.
• Keep area inspection-ready and participate in inspections; share best practice across API.

Skills

Pharma Cleaning

Cleaning Validation

Process Optimisation

GMP Knowledge

Data Analysis

Root Cause Analysis

Communication

Teamwork

Education

BSc/MSc in a relevant field

Tools

IQ/OQ/PV

Job description

Cari in Kalundborg, Denmark is seeking a Senior Process Engineer, Cleaning to maintain and improve pharmaceutical cleaning processes. You will use data and process understanding to sustain validated operations and support continuous improvement, ensuring product quality for patients.

This role requires deep GMP knowledge, 6+ years in pharma cleaning, and ability to drive investigations, validation activities and cross-functional collaboration in a global manufacturing setting.