Process Equipment Engineer

Responsibilities

• Manage the full lifecycle of process equipment, including selection, procurement, installation, commissioning, and decommissioning.
• Oversee equipment coding, asset management, and maintenance records.
• Develop and supervise equipment inspection and maintenance plans based on production schedules.
• Perform fault diagnosis and collect/analyze data on equipment operational status.
• Lead technical upgrades and propose continuous improvement solutions for production equipment.
• Ensure the safety and maintenance of equipment used in drug substance production, formulation filling, and packaging lines.
• Draft and investigate quality deviations, changes, and Standard Operating Procedures (SOPs).
• Participate in the development and review of URS, FAT, SAT, IQ, and OQ for new projects.
• Manage relationships with process equipment suppliers to ensure compliance with internal processes.

Requirements

• Bachelor's degree in Mechatronics, Mechanical Engineering, Electrical Automation, or Pharmaceutical Engineering.
• 5+ years of experience in the pharmaceutical industry.
• Proficiency in GMP equipment management systems.
• Ability to independently draft deviations, changes, and SOPs.
• Proficiency in CAD and Microsoft Office software.
• Strong organizational, coordination, and communication skills.

Preferred Qualifications

• Experience with aseptic equipment such as ORABS or isolators.
• Experience with automated packaging lines or visual inspection machines.
• Proficiency in English reading and writing skills.

About the Company

BioNTech is a leading biotechnology company pioneering novel therapies for patients with cancer and other serious diseases.