The Opportunity:

This role is responsible for supporting manufacturing processes, quality/cost-saving initiatives, and the implementation of engineering principles while ensuring compliance with cGMP, quality, and safety standards.

Responsibilities:

• Responsible for building code from scratch to support equipment upgrades and automation improvements.
• Responsible for programming and supporting manufacturing processes, including automation upgrades, quality improvements, and cost-saving initiatives.
• Responsible for managing equipment specification, acquisition, and implementation.
• Lead automation equipment upgrades efforts related to safety, obsolescence, and continuous improvement initiatives.
• Evaluate machine logic, electromechanical, and process controls to troubleshoot equipment and drive resolution.
• Mentor teams to identify the root cause of manufacturing failures using structured problem-solving.
• Applies root cause fixes to prevent recurrence.
• Conduct failure modes and effects analysis and evaluates manufacturing equipment risk.
• Completes complex projects based on comprehensive knowledge of manufacturing equipment and processes.
• Lead design of experiments, validation, completion of testing, and analysis of data.
• Presents data to cross-functional teams.
• Drive implementation of new methods or materials for continual improvement of quality and efficiency.
• Analyze current equipment for process suitability and provide detailed plans for improvement.
• Create and revise manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, procedures, and other technical documents to ensure compliant, efficient, and safe procedures.
• Lead other engineers and technicians in developing solutions and improvements in materials, equipment, and processes as necessary, in addition to ensuring continual improvement, safety, and compliance.
• Manage cross-functional project teams and coordinates activities.
• Contribute to the professional development of engineers and technicians.
• Provide training and process expertise for product processing in specific areas such as process development, tooling development, documentation, cleaning protocol, process characterization, and validation.
• Initiate and leads resolution of Quality Incidents and CAPA.
• Participate in teams as necessary and mentors' junior engineers and maintenance technicians to ensure continual improvement, safety, and compliance.
• Consider safety, ergonomics, maintenance, and operator impact on manufacturing design.
• Interact with the local Project Management Office on milestones and project status updates.
• Participate in site strategy meetings and planning.
• Provide expert-level judgment and consulting across other businesses and act as a Subject Matter Expert (SME) for applicable topics.
• Responsible for changes made through Agile PDM.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications:

• Bachelor’s degree (BS) in engineering or equivalent combination of education and experience.
• 10+ years of engineering experience in a manufacturing environment.
• Hands-on experience with machine logic and automation systems.
• Mastery in the application of Lean Six Sigma principles and the DMAIC approach or a similar structured problem-solving system.
• Proficiency in changing management principles and processes.
• Experience with Microsoft Office Suite (Excel, PowerPoint, Power BI, etc.).

Preferred Qualifications:

• Experience working in GMP, FDA, ISO, and USDA-regulated environments.
• Experience with OEM.
• Experience with statistical analysis software.

Skills:

• Innovative Thinking: Independently generates new, creative, and sometimes unconventional ideas to solve problems or improve current processes and structures while seeking feedback from managers and coworkers.
• Multitasking: Demonstrates the ability to handle multiple tasks or responsibilities simultaneously by efficiently managing time, prioritizing tasks, and maintaining productivity across different activities.
• Self-Motivated: Demonstrates a proactive attitude, consistently drives personal and team goals, and maintains high productivity with minimal external supervision.
• Verbal and Written Communication: Effectively conveys ideas in both individual and group settings, adapting style and methods to suit the audience’s needs, both verbally and in writing.
• Teamwork and Collaboration: Demonstrates professional cooperation by working harmoniously with others, being an integral part of a team, respecting others’ contributions, and aligning personal goals with those of the team.
• Engineering Competencies
• Materials Testing: Proficient in a variety of testing and measuring methods relating to the evaluation of properties and performance of materials used in manufacturing.
• CAD: Proficient in computer-aided design (CAD) and manufacturing software for designing system layouts.
• Fabrication Principles: Mastery in fabrication principles including CNC, lathe, milling, welding, and bolted connections.
• Mathematical Aptitude: Mastery in mathematical concepts such as ANSI/AQL, probability, and statistics.
• Technical Aptitude: Mastery in interpreting an extensive variety of technical instructions in mathematical or diagram form and dealing with several abstract and concrete variables.