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Automation Engineer
2 months ago
Essential Functions:
- Provide support on a daily basis to process control system, building management systems and data historian systems.
- Perform system software updates, security updates and upgrades to newer version.
- Support and enforce the data integrity program.
- Support and maintenance of computerized systems.
- OSI Soft PI Historian and reporting system configuration and maintenance.
- Maintain Functional Specifications, Database Design Specifications and Hardware Design Specifications for automation systems.
- Develop and maintain standard operating procedures and trainings for automation systems.
- Create, support and maintain customer data sharing programs that includes but not limited to secure customer web portals.
- Assist in the development and implementation roadmap for the deployment of automation technologies.
- Execution of engineering test plans, factory acceptance test and site acceptance test.
- Assist in the development of software test specification, user requirements and functional specifications.
- Maintenance of automation related systems and configuration backup codes.
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation and industry codes.
- Knowledge of cGMP practices utilized in bulk drug, gene therapy, final formulation filling and vaccine manufacturing environment.
- Support computer system validation to ensure that appropriate regulations (e.g. 21 CFR Part 11 and cGMP) are addressed in a development phase and implementation level.
- Interfaces with IT to ensure GMP compliant integration with corporate IT infrastructure.
- Performs other duties as assigned.
- Desired experience with process control, building management, data historian, remote notification and manufacturing enterprise systems.
- Understand automation protocols like: HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC, OPC UA and Modbus TCP/IP.
- Assist in training of automation systems.
- Reliable, self-motivated individual with positive attitude; team-oriented with the ability to work with staff covering a variety of roles.
- Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities.
- Strong written, verbal and interpersonal communications skills.
- Must be able to work effectively and efficiently with minimal supervision in a schedule-driven, ever-changing work environment.
- Working knowledge of MS Office products (Word, Excel, Outlook, and Power Point).
- Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
- Bachelor Degree preferably in Electrical, Mechanical, Chemical Engineering with one (1) year experience.
- Experience with critical and non-critical utilities, biotechnology equipment and complex pharmaceutical systems are a plus.
- At least 3 years of relevant automation engineering experience in the biotechnology /pharmaceutical industry.
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