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Position Title: Automation Engineer (Advanced Drug Delivery Devices)
Reports to: Engineering Director/Manager
Location: Philadelphia, PA

SUMMARY:

• The main functions of an Advanced Drug Delivery Devices (ADDD) Automation Engineer are:
• Conceptualize manufacturing processes in support of new business opportunities (Sales/Business Development Support)
• Develop specifications (URS), manage assembly automaton build with selected vendor, participate in validation, and manage transition sustaining product support,
• Serve as automation lead on NPI teams for new product launches
• Manage new equipment specification and build established budget and timeline
• Activities are focused on bringing new equipment and product-specific equipment variants in the site.
• This includes working with the customers define the specifications, capacity and flexibility requirements.
• Initial project activity includes writing the URS, leading the pFMEA effort, and working with the equipment supplier monitor build progress.
• Upon build completion, FAT, SAT and full validation (IQ, OQ, PQ) are part of the role.
• A strong statistical background is required to be able perform equipment DOEs, process optimization, MSAs and Cpk analysis. Transfer production requires training and support of the teams, and ensuring a robust and safe production process is in place.
• This is achieved through individual effort and facilitation of teams, tracking and analysis of metrics, strong understanding and utilization of good engineering practices, project management, and the use of Lean Six Sigma techniques.

ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING (OTHER DUTIES MAY BE ASSIGNED):

• Management of the Equipment Acquisition and Validation Process Including:
• Specifies equipment needed (URS), prepares RFQs, and obtains quotes from vendors.
• Applies sound engineering principles define URS, production line design, and component layout, with a goal of designing a process capable of low defects (less than 1%), high uptime (greater than 95%), low waste (less than 1%), and throughput better than estimate.
• Writes CER's (Capital Equipment Requests) for new owned equipment, including researching the justification.
• Upon approval, negotiates, orders, and manages build of equipment meeting established budget and timeline.
• Participate in internal project review meetings with plant-wide leadership prepare for successful launch.
• Write and execute protocols for FAT (Factory Acceptance Tests) and SAT (Site Acceptance Tests).
• Writes and executes the measurement system analysis including Gage R&R studies on measurement systems
• Manages the technical risk by developing a pFMEA with a strong control plan
• Use DOE (Design of Experiments) perform process development in a controlled manner.
• Define the process capability Cpk of critical assembly stations
• Responsible for determining OQ parameters start validation.
• Commissioning of equipment including all necessary change controls and training.
• Provide new opportunity (sales) support:
• Conducts and/or participates in customer meetings. Interacts with Sales and customers determine requirements for new products/orders.
• Define processes for new device assembly business.
• Analyzes customer requests determine equipment, tooling, or delivery systems needed.
• Support new proposal development by preparing equipment/engineering estimates for potential projects.
• Researches new trends and technologies in assembly automation and drug packaging; evaluates and tests new equipment and processes.
• Provide technical leadership/coaching the engineering team.
• Be able provide back-up for other NPI engineering value streams.
• Applies sound engineering principles to improve existing equipment, packaging design and processes by reducing waste, increasing throughput, reducing energy consumption or eliminating human interaction through automation. Working with teams on multiple shifts as needed.
• Leads CAPA investigations and actions, applying Lean Sigma concepts and DMAIC or similar problem-solving methods. Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, poor quality and/or unsafe design.

SUPERVISORY RESPONSIBILITIES:

• No supervisory responsibilities.

EDUCATION OR EQUIVALENT:

• Bachelor of Science in Engineering and/or 10+ years of industry experienced required
• 5+ years relevant experience in equipment purchasing and validation, process improvement, and project management
• Six Sigma Green Belt or Black Belt certification preferred.
• Drug-device combination product assemblyand/or pharmaceutical background preferred.

KNOWLEDGE SKILLS REQUIREMENTS:

• Expertise with assembly, packaging, and serialization automation equipment, with GAMP5 methodology preferred.
• Strong expertise with applied statistics for manufacturing process capability and variation reduction.
• Highly effective communication skills (verbal and written form).
• Effective at leading project teams and interfacing with customers and operations personnel.
• Ability to prepare and execute a project plan
• Must possess and demonstrate motivational and leadership qualities.
• Must possess excellent problem solving and analytical skills.
• Must be well organized along with being detail and multi-task oriented.
• High level of knowledge and experience in cGMP is desirable.

COMPUTER SKILLS:

• Fully competent in the use of computer software Microsoft Windows, Microsoft Word, Microsoft Excel and Microsoft Power Point.
• Ability to use Microsoft Project or similar project management software, Visio, Minitab or similar statistical software, AutoCAD or similar 3D CAD software.