TM - Plant Engineering DS I&A

Summary:

Experienced Team member to handle Instrumentation & Automation (I&A) function in Drug Substance manufacturing plant. This role plays a critical part in ensuring the smooth operation, efficiency, and regulatory compliance of our biopharmaceutical manufacturing processes. To join a team of technicians responsible for maintaining, troubleshooting, and optimizing a complex network of instrumentation and automation systems.

Responsibilities:

• Implement strategies for the preventative maintenance of all I&A equipment within the Drug Substance manufacturing area.
• Perform qualification of I&A equipment according to cGMP and regulatory requirements.
• Troubleshoot and resolve I&A system malfunctions, ensuring minimal disruption to production timelines.
• Work collaboratively with other engineering personnel, production teams and quality assurance to identify opportunities for process optimization through automation.
• Stay current on advancements in I&A technology relevant to biopharmaceutical manufacturing.
• Manage and maintain technical documentation for all I&A systems.
• Prepare and participate in audits and inspections related to I&A systems.
• Ensure adherence to all safety regulations and procedures within the manufacturing plant.

• Bachelor's degree in Engineering (in instrumentation/electronics & communication/ electrical/Computer Science) or a related field.
• Minimum 5 years of experience in a biopharmaceutical or similar aseptic manufacturing environment with a focus on I&A.
• Proven experience in a technical environment.
• Strong understanding of cGMP regulations and GAMP® 5 guidelines.
• In-depth knowledge of biopharmaceutical manufacturing processes and equipment.
• Experience with common biopharmaceutical manufacturing automation systems (e.g., DCS, SCADA, PLC).
• Troubleshooting and problem-solving skills.
• Strong communication, interpersonal, and collaboration skills.
• Ability to prioritize and handle multiple tasks in a fast-paced environment.

About the DepartmentBiologics