Hybrid Role (Traveling to CDMO sites, Bloomington, IN being the main one)
Reporting to the Senior Director of Global Engineering, the Principal Engineer will be the subject matter expert (SME) of the Vision Inspection Equipment and Systems for Clients Drug Product Manufacturing. The candidate will lead Inspection Vision Equipment and Systems of primary DP filled containment of sterile operations as the primary Engineering discipline for Capital Projects throughout the Cleints global footprint for both Clinical and Commercial supply operations. Additionally, candidate will also play an active role in providing guidance to existing manufacturing facilities including contract manufacturing sites.
He/she may serve as the overall project lead or project technical lead. The role requires the ability to manage multiple contractors and a portfolio of technical projects at the same time.
Here’s What You’ll Do:
- Responsible for vision systems equipment specification development.
- Lead on Front End Planning (FEP) activities for the vision equipment scope on capital projects and programs within the global client – determining provisional scope, design, manufacturability, cost, capital, risk, and schedule considerations while working with cross-functional teams.
- Key contributor to/perform equipment vendor selection and assessments
- Provide input to user requirements, design specifications, process parameters, and FMEA assessments.
- Be the owner of vision systems best practices and functional standards that enables global standardization of process, equipment and systems.
- Translate the business needs of the company into engineering solutions and develop a thorough knowledge of the commercial and clinical inspection system needs to prepare project scopes. Incorporate business foresight of emerging technological trends, applying technology in innovative ways.
- Serve the global organization as a Subject Matter Expert in vision inspection systems. Develop and gain alignment on procedures and standards within internal, cross-divisional teams.
- Independently execute, and direct others in the execution of, the design of processes and equipment by applying novel engineering concepts and techniques within the discipline. Benchmark internally and externally to investigate and recommend such designs.
- Identify new technologies for vision equipment, including implementation of AI. Design and conduct testing to evaluate these new technologies and equipment changes as part of the technical roadmap. Provide technical support to clients external supply manufacturing network including existing system issues as well as design improvements/new designs as part of continuous improvement, and act as a technical influencer to senior leadership and stakeholders for business initiatives.
- Drive results by owning and completing capital projects and meeting the project timelines to ensure the schedule is not impacted.
- The Vision Equipment Engineer will participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.
- Troubleshooting equipment to determine root cause of failure modes, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.
- At the level of Principal Engineer, the candidate must be able to drive results on multiple complex assignments simultaneously, in addition to reviewing and guiding the work and performance of vendors and consultants.
- Drive development of Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required
Experience outweighs, 10+ year in GMP is a MUST
Hybrid: Principle Engineer Vision Equipment (233769)