
TM - Plant Engineering DS I&A
2 days ago
- 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.
Benefits Offered
Our Work Culture
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