
Automation and Instrumentation Engineer
1 day ago
Job Description:
As an Automation and Instrumentation Engineer, you will play a critical role in ensuring the smooth operation, efficiency, and regulatory compliance of our biopharmaceutical manufacturing processes. You will be responsible for maintaining, troubleshooting, and optimizing a complex network of instrumentation and automation systems.
Responsibilities:
1. Implement strategies for the preventative maintenance of all I&A equipment within the Drug Substance manufacturing area.
2. Perform qualification of I&A equipment according to cGMP and regulatory requirements.
3. Troubleshoot and resolve I&A system malfunctions, ensuring minimal disruption to production timelines.
4. Work collaboratively with other engineering personnel, production teams, and quality assurance to identify opportunities for process optimization through automation.
5. Stay current on advancements in I&A technology relevant to biopharmaceutical manufacturing.
6. Manage and maintain technical documentation for all I&A systems.
7. Prepare and participate in audits and inspections related to I&A systems.
8. Ensure adherence to all safety regulations and procedures within the manufacturing plant.
Qualifications:
- Bachelor's degree in Engineering, 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.
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