Senior Manufacturing Systems Engineer – Rockwell – Siemens – And B&R

Senior Manufacturing Systems Engineer – Rockwell – Siemens – And B&R

Requirements

• Doctorate degree
• Or Master’s degree & 2 years of engineering experience in a GMP environment
• Or Bachelors degree & 4 years of engineering experience in a GMP environment
• Or Associate degree & 8 years of engineering experience in a GMP environment
• Or High school diploma / GED and 10 years of engineering experience in a GMP environment

Responsibilities

• Develop, organize, analyze and present interpretation of results for operational issues or engineering projects of significant scope and complexity
• Complete sophisticated or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.

Preferred Qualifications

• Advance degree in Computer, Electrical, Mechanical, Chemical Engineering, or Biomedical 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
• Expertise in Machine Vision (Cognex) and Rockwell software platform
• Knowledge in Deep Learning
• Direct experience with leading and managing Systech Serialization projects including experience with Guardian, Advisor, Sentri, and other Systech ancillary devices.
• 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
• Excellent communication skills together with ability to work in a team environment.
• Organizational, project management, problem-solving, as well as validation protocol and technical writing capability
• Track record of leading and executing multi-functional projects.
• Strong teamwork, excellent interpersonal and communication skills.
• Direct experience with medical devices/combination products and associated manufacturing processes.
• Experience in working with third-party vendors and equipment suppliers.
• Ability to work in a highly regulated and ever-changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast paced environment.
• An Operational Excellence and Lean Transformation approach to work product – driving rapid results.
• A passion to deliver an excellent work product and develop others with an infective positive attitude!