Senior Engineer, Automation
The Senior Engineer, Automation is responsible for the technical automation support and lifecycle management of FPGs automated systems. This role will serve as the Subject Matter Expert (SME) for designing, implementing, integrating, maintaining and optimizing the company’s automation technologies that control, monitor and support the manufacturing process and associated utilities. The Automation Senior Engineer will provide leadership for automation project execution from concept, specification, development, integration, testing to start-up; and will require direct interface with project teams and clients to ensure alignment with project objectives.
This role is also responsible for driving technical improvements, while ensuring compliance with industry best practices and regulatory requirements.
- Responsible for interfacing with department leadership and project managers to ensure appropriate level of technical support and direction are provided. This position will work closely with the Process Engineering, IT and validation & QA teams to set directions for standardized and optimized automation engineering practices associated with process and facilities equipment.
- Responsible for the support and execution of automation qualification and applicable software validation. Maintain the safe and qualified automation design and operation of process and facilities equipment. Manage the design and implementation of automated systems and perform the qualification or validation steps (FAT, SAT, commissioning, IQ, OQ and PQ) according the GAMP 5.
- Provide oversight on automation engineering design standards and practices. Local project management and oversight of inter-related activities including resource planning, tasks assignment and priorities.
- Establish and maintain technical standards and SOP’s for automated systems and equipment (Building, Manufacturing and packaging equipment), and associated network infrastructure. Implement updates of the systems, coordinate/perform the preventive and corrective maintenance on automated systems; update the technical and validation documentation after modifications on systems.
- Provide investigational and problem-solving support to end users/shop floor, with a focus on system enhancement and sustainability to prevent future occurrence of system issues. Assist with investigation documentation and impact assessments, assist in identification and execution corrective and preventative actions (CAPAs).
- Degree in Engineering (Electrical, Computer Science, etc.) or related field.
- 8+ years of experience in designing, programming and maintenance of control systems and data acquisition systems, preferably in GxP Environment.
- In-depth knowledge and experience in the following area of responsibility: Pharmaceutical Manufacturing Process, Engineering Design, Capital Project Mgt, Project Scope Definition, Budget Preparation and Management, On-Demand Operational Support.
- Expertise in Software Lifecycle Mgt & Documentation, Technical evaluations, and Drafting & Executing Test Plans within GxP environment; strong knowledge of GAMP 5.
- Familiarity with ISA S88/S95 standards.
- Preferred: Knowledge of Historian, MES, Industry 4.0, IIoT, and Smart Manufacturing technologies, Allen Bradley Control Logix, Siemens SIMATIC, Rockwell Automation (AB Control Logix).