API Manufacturing Professional for Downstream

Category: Manufacturing

Location:Hillerød, Capital Region of Denmark, DK

• Implementing the manufacturing process in our new equipment, software, and automation systems, ensuring that all process requirements are met and continuously monitoring the process to ensure efficiency and compliance.
• Ensuring the facility is ready for operation by preparing Standard Operating Procedures (SOPs) for production and developing training procedures in collaboration with operators and other users.
• Designing the day-to-day operation of the facility, workflows, and communication between teams, and monitoring the process.
• Developing and providing input to protocols for final on-site verification of equipment installation and operation, and executing these tests along with other validation tests in close collaboration with downstream team members, CQV-engineers, and technical disciplines.
• Collaborating with local engineering partners, downstream colleagues, and ER/OR’s from other discipline areas (automation, upstream, utility, logistics) and suppliers to agree on equipment, technical, process, and automation topics related to manufacturing.

• Ensure stable production of the running manufacturing facility.
• Perform re-qualifications and handle deviations and compliance issues.
• Support operators and maintenance personnel.

• An academic degree within engineering, pharmaceutical science or similar
• Experience with working in pharmaceutical production, API production experience is an advantage
• Full professional proficiency in written and spoken English.