Project Engineer Sterile Injectables

Project Engineer Sterile Injectables
This service supports the
development and optimization of robust processes
for both
new and commercial sterile injectable drug products
. It focuses on
small-scale process design
and
hands-on laboratory execution
, bridging development and manufacturing.

Key activities include:

• Designing and executing
  small-scale process development projects
• Collaborating with internal and external stakeholders
  to ensure correct project scoping and execution
• Writing
  protocols, reports, and technical documentation
• Supporting the
  connection of small-scale manufacturing equipment
  to the company network within a laboratory environment
• Ensuring full
  compliance with laboratory procedures
  , safety standards, and quality requirements

The service operates within a regulated pharmaceutical environment and contributes to continuous improvement while maintaining high standards for safety, data integrity, and operational excellence.

Perfect Candidate Profile (Medior Level)

Education & Background

• Master's degree in
  Bio-engineering, Industrial Pharmacy, Biotechnology, Biochemistry, Industrial or Civil Engineering
  , or a related scientific/technical field

OR
- Equivalent experience gained through relevant professional practice

Technical Expertise

• Experience in
  pharmaceutical production or development environments
• Solid understanding of
  aseptic processes
  , preferably in
  sterile injectable manufacturing
• Knowledge of or exposure to:
• Cleaning, disinfection, and sterilization processes
• Small-scale manufacturing or laboratory equipment
• GMP-regulated environments
• Comfortable working
  hands-on in a lab setting
  while following strict procedures
• Ability to support
  equipment integration with IT/network systems
  in a laboratory context

Way of Working (Medior Service Level)

• Consistently executes
  operational tasks independently
  within established procedures
• Delivers
  reliable, accurate output
  that contributes to team and project objectives
• Supports decision-making using
  predefined criteria and data
• Collaborates effectively with
  other service streams and stakeholders
• Actively participates in
  continuous improvement initiatives
• Adheres to
  service standards, safety rules, and quality requirements

Communication & Soft Skills

• Strong
  technical writing skills
  (protocols, reports, documentation)
• Clear and professional
  verbal communication
• Proven
  stakeholder management
  abilities across functions and partners
• Well-organized, detail-oriented, and quality-focused
• Able to thrive in a
  rapidly changing, project-driven environment

Language Skills

• Fluent in Dutch and English
  (spoken and written)

Ideal Candidate Snapshot

Hands-on, scientifically trained professional

Comfortable in sterile, regulated lab environments

Strong in execution, documentation, and collaboration

Reliable contributor at medior level with growth potential

Safety- and quality-minded, with a continuous improvement mindset

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