Regulated Manufacturing Engineer
3 days ago
We are a dynamic technology-driven company that's transforming the way medicine is produced. Our mission is to establish a sustainable network of high-tech manufacturing solutions, enabling us to better withstand disruptions, support scientific discovery, and reach those in need.
Job Overview
This is an exciting opportunity for a highly skilled Regulated Manufacturing Engineer to join our Inspection, Device Assembly and Packaging PET team. As a Regulated Manufacturing Engineer, you will be responsible for overseeing project management, ensuring the operation and maintenance of all assets within the facility, and leading improvement initiatives as a technical expert. You will also provide technical support for project-related work, collaborating with operations, engineers, other leaders, and OEM suppliers.
Responsibilities
• Plan and coordinate specialist engineering activities within the Inspection, Device Assembly and Packaging PET team.
• Oversee project management and ensure the operation and maintenance of all assets within the facility.
• Lead improvement initiatives as a technical expert and drive root cause analysis and perform/facilitate technical investigations and assessments.
• Collaborate with operations, engineers, other leaders, and OEM suppliers to provide technical support for project-related work.
• Interface with various types of equipment and systems, including PLCs, SCADAs, HMIs, Servers, Databases, Data Historian, Visualization, and automation equipment.
• Develop project justification and engineering proposals, evaluate new software and/or tools, and maintain external technical relationships.
• Train team members on equipment, processes, and Standard Operating Procedures for new products, market launches, or clients.
• Key contact for regulatory inspections as technical process owner.
Qualifications
• Bachelor's degree in Engineering, Computer Science, or related discipline.
• Experience supporting manufacturing operations in a regulated or cGMP environment.
• Experience with Automation systems; PLCs, HMIs, SCADA, Rockwell Inductive (Ignition) Aveva (Wonderware), Siemens, Emerson (GE), or B&R.
• Ability to interpret diagrams, drawings, PLC code, and other schematics.
Benefits
The estimated salary range for this position is $80,000 - $113,750 per year, depending on factors such as geographical location, relevant experience, qualifications, skills, and knowledge. We offer a competitive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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