At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Automation Engineer will primarily be responsible for maintaining Eisai automation and site control systems. The position will have the high level of knowledge and experience with SCADA, PLC and HMI programming along with providing maintenance for these systems. The Engineer will have knowledge and demonstrated use of programmable logic controllers and associated I/O’s. They will assist department leadership with the management of code, software and backups and be the System Administration of the site control system hardware and network.
The Automation Engineer will be accountable for completing actions assigned. They will assist department leadership to resolving technical issues and ensure adherence to applicable policies and procedures. The Automation Engineer must be able to work both independently and as a team member and handle multiple tasks/assignments simultaneously, and work with minimal supervision.
The Automation Engineer will conduct deviation investigations, communicate findings, and provide solutions to cross functional teams. The position will communicate findings verbally and in writing while creating mitigating actions to ensure reliability of equipment. They will assist department leadership to drive continuous improvement projects and create business solutions independently. The Automation Engineer shall also be able to provide technical support to the facilities, operations, quality and validation groups.
1. Assist in the maintenance of automation systems and implementation of solutions to changing requirements, ensuring safety, regulatory compliance, company standards, operational requirements and business needs. Actively participate in cross-functional team discussions representing Automation.
2. Perform PM activities related to SCADA Server and Client checks, PLC Control Panel Checkouts, Software Backups.
3. Write/review SOPs pertinent to Automation systems and maintain documentation for the various Automation systems (URS, FS, DS, P&IDs, electrical drawings, etc).
4. Prepare/execute Automation qualification documents for plant equipment, facilities, utilities and computer systems in support of GMP / FDA requirements. Provide oversight for automated control system validations as required.
5. Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines.
6. Assist in troubleshooting product and equipment issues and deviations.
7. Interact cross-functionally with Operations, Facilities, Quality, Validation, and other internal and external functions to support successful product development.
* Education: BS is required. Engineering or relevant field is preffered.
* Minimum 3 - 4 years experience in automation manufacturing environment.
* Minimum 3 years experience in a GMP compliant manufacturing facility including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment.
* Demonstrated history of maintaining, analyzing and troubleshooting of SCADA and programmable logic control systems - Wonderware and Allen-Bradley a plus.
* Experience with management of logic controllers software, backups and supplies including vendor relations, parts inventory requests and sourcing, and interdepartmental consultations.
* Hands on experience with communication protocols including but not limited to RS-485, RS-232, Ethernet, Data Highway Plus, Modbus & Profibus.
* Strong problem solving and reasoning skills.
* Ability to maintain control in stressful situations, and perform well under pressure.
* Ability to identify, investigate, and troubleshoot basic process and equipment problems.
* Working knowledge of cGMP, EMEA, and JP regulations.
* Good written and communication skills.
* Good problem solving and interpersonal skills with the ability to work in a team environment required
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
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