R-107233 Automation Engineer II

Job Description

Job Description

Position Summary

The Automation Engineer II is an engineer responsible for enhancing programs across a broad spectrum of functions at the West Chester Site. In this role, you will lead and advise on projects spanning various departments within the site, including Formulation, Aseptic Filling, Automated Inspection, Device Assembly, Packaging, Building Automated System, AMHS, and a site-level Historian system. Collaboration with cross-functional teams, such as MS&T, Engineering, Digital, Quality, Validation, and other key stakeholders, is integral to defining requirements, project execution, and the sustained operation of multiple automated systems on-site.

This position is an excellent fit for Automation Engineers who possess problem-solving abilities and a service-oriented mindset. It provides an opportunity for professionals to expand their technical expertise while gaining exposure to a diverse array of systems and actively contributing to their growth and optimization.

Responsibilities

• Participate and support in the design, optimization, commissioning, or validation of newly procured or existing equipment as the automation lead.
• Interface with several types of equipment and systems, including but not limited to PLCs, SCADAs, HMIs, Servers, Databases, Data Historian, Visualization, and other automation equipment.
• Consult cross-functionally and assist system owners in process development as the automation subject matter expert. 
• Review and approve requirements, specifications, drawings, coding procedures, and guidelines.
• Provide technical guidance and train others on systems, software, equipment, machines, procedures, and/or processes.
• High technical ability with a troubleshooting approach
• Identify temporary and permanent fixes to address issues.
• Review and approve documentation needed for the qualification of equipment and processes.
• Author, review, and revise SOPs and specifications to maintain equipment, systems, and/or facilities. Comply with all SOPs.
• Ensure proper documentation practices during maintenance processes.
• Recommend and initiate activities to ensure area and equipment are maintained in a state of compliance.
• Assess and implement improvements in productivity, waste generation, quality, and cost.
• Lead and coordinate investigations and studies with little supervision.
• Interact with regulatory agency personnel during audits and inspections.
• Perform quality audits to ensure devices used are in proper working condition. 
• Provide 24/7 support to others as part of a rotating on-call support system.
• All other tasks as needed or assigned by the supervisor.

Minimum Qualifications

• Experience supporting manufacturing operations in a regulated or cGMP environment
• Experience with some of the following Automation systems (PLC, HMI, SCADA): Rockwell, Inductive (Ignition), Aveva (Wonderware), Siemens, Emerson (GE), or B&R 
• Ability to work independently with excellent attention to detail and a desire to learn about manufacturing technologies

Preferred Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related discipline
• Experience with FactoryTalk Batch
• Experience with Data Historian and Visualization systems such as Aveva PI (OSI PI)
• Experience with Microsoft SQL database design 
• Knowledge of GAMP 5 and ISA standards
• Knowledge of change control, deviation, CAPA, validation, and qualification principles 

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

Company Description

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.