Sr Engineer - Electrical

Pay range: 45-55/hr
*depending on range

The Engineer position reports to the Manager of Engineering under the Engineering & Maintenance team at the Ohio facility. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the Ohio manufacturing facility. Based in New Albany, Ohio, the site of new advanced product assembly and packaging plant, this role will apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, processes, and/or capital projects.

In this role, the Mfg. Systems (Automation) Engineer will:
Key Responsibilities:
1. System Design and Development:
o Design and develop automation systems and control strategies for packaging machinery and processes.
o Implement and configure Programmable Logic Controllers (PLCs), Human-Machine Interfaces (HMIs), and other automation equipment.
o Create and maintain detailed documentation, including system specifications, design documents, and operational procedures.
2. Integration and Optimization:
o Integrate new automation technologies and equipment into existing packaging systems.
o Optimize control processes to enhance efficiency, reduce waste, and improve product quality.
o Conduct feasibility studies and cost-benefit analyses for automation projects.
3. Troubleshooting and Support:
o Diagnose and resolve issues with automation systems and control equipment.
o Provide technical support and troubleshooting for production and maintenance teams.
o Perform system upgrades and maintenance to ensure optimal performance and reliability.
4. Compliance and Quality Assurance:
o Ensure that all automation systems comply with FDA regulations, GMP standards, and industry best practices.
o Collaborate with Quality Assurance and regulatory teams to address any compliance or quality issues related to automation.
5. Project Management:
o Lead and manage automation projects, including planning, execution, and monitoring.
o Coordinate with cross-functional teams to ensure timely and successful project completion.
o Prepare and present project reports, performance metrics, and technical documentation.
6. Training and Development:
o Train and support staff on the use and maintenance of automation systems.
o Develop training materials and conduct workshops to enhance team competency in automation technologies.

The position is a key role in the Engineering and Maintenance department and the candidate must manage and apply extensive technical expertise in the coordination of multiple, sophisticated, non-routine projects involving the planning, design, reconfiguration, construction, maintenance, validation and alteration of systems, facilities and processes. This position will also be required to apply advanced and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, optimization, scale up or manufacturing support projects.

Production Support
Key responsibilities will include working with the engineering and maintenance team to support the commercial production packaging lines. Additional responsibilities will include providing technical operations support for continuously improving the packaging lines' capacity and performance and advising on technical improvement projects. The Engineer must ensure effective communication throughout the commercial site network with all stakeholders and deliver on technical improvements.

Basic Qualifications:
Masters degree
Or
Bachelors degree and 2 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
Or
Associates degree and 6 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
Or
High school diploma/GED and 8 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries

Preferred Qualifications:
• Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
• Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
• Knowledge in Data Integrity and Security
• Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, field instrumentation technologies
• Exposure to Machine Vision, Serialization, Robotics, Siemens, and Rockwell software platform
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment
• Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
• Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
• Excellent communication (verbal/written) and presentation skills
• Demonstrated interpersonal skills, including: collaboration, influencing, and facilitation
• Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context