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Automation Systems Specialist
2 months ago
Salary:
We are seeking an experienced Automation Systems Specialist to join our expanding automation team at CPMNA. This role involves providing technical and operational support, executing critical projects, and ensuring the installation, operation, maintenance, and troubleshooting of automation systems to achieve organizational objectives.
Key Responsibilities:
- Offer daily support for process control systems, building management systems, and data historian systems.
- Conduct system software updates, security enhancements, and upgrades to newer versions.
- Uphold and enforce the data integrity program.
- Support and maintain computerized systems.
- Configure and maintain OSI Soft PI Historian and reporting systems.
- Maintain Functional Specifications, Database Design Specifications, and Hardware Design Specifications for automation systems.
- Develop and uphold standard operating procedures and training programs for automation systems.
- Create and maintain customer data sharing programs, including secure customer web portals.
- Assist in the development and implementation roadmap for deploying automation technologies.
- Execute engineering test plans, factory acceptance tests, and site acceptance tests.
- Contribute to the development of software test specifications, user requirements, and functional specifications.
- Maintain automation-related systems and configuration backup codes.
- Perform all duties in compliance with applicable laws, regulations, and industry standards.
- Demonstrate knowledge of cGMP practices in bulk drug, gene therapy, final formulation filling, and vaccine manufacturing environments.
- Support computer system validation to ensure compliance with regulations (e.g., 21 CFR Part 11 and cGMP) during development and implementation.
- Collaborate with IT to ensure GMP-compliant integration with corporate IT infrastructure.
- Complete other assigned duties as necessary.
Required Skills & Qualifications:
- Experience with process control, building management, data historian, remote notification, and manufacturing enterprise systems.
- Familiarity with automation protocols such as HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC, OPC UA, and Modbus TCP/IP.
- Assist in training personnel on automation systems.
- Reliable, self-motivated individual with a positive attitude; able to work collaboratively with diverse teams.
- Strong time management skills and ability to prioritize tasks effectively.
- Excellent written, verbal, and interpersonal communication skills.
- Ability to work independently and efficiently in a dynamic, schedule-driven environment.
- Proficient in MS Office applications (Word, Excel, Outlook, PowerPoint).
- Willingness to work in a fast-paced, state-of-the-art research and customized manufacturing facility.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. While performing the duties of this job, the employee is regularly required to:
- Engage in prolonged sitting, standing, bending, stooping, climbing, and stretching.
- Utilize hand-eye coordination and manual dexterity to operate office equipment.
- Regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
- Work in noisy environments.
- Travel up to 10% of the time.
- Support manufacturing activities on a 24/7 basis.
- Attendance is mandatory.
Minimum Qualifications:
- Bachelor's Degree in Electrical, Mechanical, or Chemical Engineering with at least one year of relevant experience.
Preferred Qualifications:
- Experience with critical and non-critical utilities, biotechnology equipment, and complex pharmaceutical systems is a plus.
- A minimum of three years of relevant automation engineering experience in the biotechnology or pharmaceutical industry.