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Process Automation Specialist
2 months ago
Position Overview:
The Automation Engineer 2 plays a crucial role in the maintenance and enhancement of automation systems within a regulated environment. This includes executing daily checks to ensure data integrity and making necessary adjustments to system configurations for process, building, or historian automation needs. The role requires the individual to have a primary focus on a specific system, such as DeltaV, PLC, Client, or PI, while also being equipped to assist with all automation systems as needed.
Work Arrangement: On-site
Key Responsibilities:
- Leverage engineering expertise to provide automation solutions for the development of custom manufacturing equipment for a human acellular vessel product, under the guidance of senior team members or management.
- Maintain and support the existing PI data historian in manufacturing and research facilities.
- Collaborate with senior engineers to assist in the installation and validation of a PI data historian for the manufacturing facility.
- Facilitate the installation and validation of a DeltaV system for manufacturing processes.
- Assist in the installation and validation of a building automation system for the facility.
- Support the installation and validation of both OEM and custom PLCs for manufacturing processes.
- Work with the process development team to test prototype equipment and independently develop automation for custom research and development equipment.
- Ensure transparency in process development activities through regular updates to management and cross-functional teams.
- Troubleshoot automation issues during development, technology transfer, and manufacturing.
- Conduct comprehensive system tests to validate the reliability of custom automation solutions.
- Oversee the transition of automated equipment to meet regulatory and quality control standards.
- Contribute to the creation of automation documentation, including functional requirements, design specifications, test protocols, SOPs, and reports.
- Respond to automation-related alarms during standard working hours and provide on-call support as necessary.
- Assist with regulatory submissions as required.
- Perform additional duties as assigned.
Essential Skills:
- Proven knowledge in developing and supporting automation for manufacturing processes.
- Experience with automation in bioprocess applications within a GMP facility.
- Understanding of cGMP compliance in biotech manufacturing environments.
- Familiarity with 21 CFR 1271 regulations is advantageous.
- Detail-oriented, self-driven, and scientifically motivated.
- Strong analytical and problem-solving capabilities.
- In-depth knowledge of GMP quality systems.
- Excellent communication and interpersonal skills.
Qualifications:
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or a related field is required.
- A minimum of 3 years of experience in process and equipment automation.
- At least 3 years of relevant experience in the pharmaceutical or biotech industry.
- Familiarity with automation platforms such as Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC, and/or Johnson Controls.
- Experience with the installation and support of PI historian systems.
- Background in Automation, Electrical Engineering, or Mechanical Engineering.
- Knowledge of standard bioprocessing techniques and laboratory equipment.
- Willingness to work in a clean room environment and adhere to gowning and personal protective equipment protocols.
