Process Specialist - Pharma

Process Specialist – Biopharmaceutical Manufacturing | Greater Copenhagen

Overview

An exciting opportunity has opened for a Process Specialist to join our client's dynamic project team working with cutting-edge biopharmaceutical manufacturing technologies. This role is based in the Greater Copenhagen area and is ideal for an experienced professional with a background in GMP manufacturing, engineering, and process optimization.

Key Responsibilities

✅ Process Equipment Design & Implementation:

• Design, specify, and oversee the installation of new process equipment
• Provide technical support and troubleshooting for Upstream (Cell Culture), Downstream (Purification), Clean Utility/CIP, and Solution Preparation systems

✅ Project & Stakeholder Management:

• Collaborate with engineering providers, vendors, project teams, and user groups to ensure smooth project execution
• Review URS, technical documentation, and validation materials, challenging technical changes to ensure the best solutions are implemented

✅ Supervision & Technical Support:

• Provide design guidance, supervision, and review during project execution
• Oversee installation and commissioning activities, working closely with the commissioning team
• Lead equipment modifications and drive technical changes, including risk assessments and troubleshooting

✅ Validation & Training:

• Review validation protocols and support commissioning and qualification of new systems
• Deliver technical training to production teams to ensure operational excellence

Requirements

🎓 Education & Experience:

• Bachelor’s Degree or higher in Engineering, Biotechnology, or a related discipline
• 10-15 years of experience in GMP manufacturing, engineering, or pharmaceutical facilities

🛠 Technical & Project Expertise:

• Strong experience with process equipment in a commercial GMP environment
• Project management and risk management expertise in complex settings
• Ability to navigate multidisciplinary teams and stakeholders

📌 Soft Skills & Attributes:

• Detail-oriented with a problem-solving mindset
• Self-driven, proactive, and adaptable to a fast-paced environment
• Strong communication skills in English (spoken & written)

Why Join?

🚀 Innovative Environment: Work with the latest biopharmaceutical technologies

📚 Professional Growth: Gain exposure to complex projects and global industry standards

💡 Impactful Role: Contribute to the development of life-saving therapies

This is a fantastic opportunity for a highly skilled Process Specialist to work with state-of-the-art equipment in an advanced biomanufacturing environment.

Would you like any adjustments or additional emphasis on specific areas? 🚀