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Hi,

Hope you are doing well,

This is Bhanu from Intellectt INC; we have an immediate opportunity with one of our clients. Please find the below job description and if you are interested, please forward your resume to bhanuprakash@intellectt.com

Role: Electrical and Controls Engineer (Advanced Drug Delivery Devices)
Location: Philadelphia, PA Onsite
Duration: Long Term

Description:

The main functions of an Advanced Drug Delivery Devices (ADDD) Controls Engineer are:

• Evaluate suitability of existing assembly platforms to accommodate program-specific variants (Sales/Business Development Support)
• Serve as controls lead on NPI teams for new product launches, assuming ownership for configuration of the parameters and settings to be used for each product variant.
• Team member for new specification development (URS), assembly equipment validation, and transition to sustaining product support,
• Manage controls configurations for new or modified equipment to established budget and timeline
• Activities are focused on bringing new equipment and product variants on existing equipment into the site. This includes working with the customers to define the specifications, capacity and flexibility upfront.
• A strong electrical and control systems background is important for assembly equipment/component specifications, writing and debugging PLC code, debugging and optimizing vision system code, sensor management and smart factory development.
• Transfer to 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 metrics, strong understanding and utilization of good engineering practices, project management, and the use of Lean Six Sigma techniques.

Roles and Responsibilities:

• Management of Product-Specific Assembly and Packaging Process Configuration and Validation, including:
• Function as the controls and configuration subject matter expert to specify equipment needs (URS), whether for new equipment or adaptation of existing equipment for new programs.
• Write, analyze, and debug code to meet program-specific needs for PLC, vision system, etc. configurations, and configuration management across multiple programs.
• Applies sound engineering principles to 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.
• Participate in internal project review meetings with plant-wide leadership to 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) to perform process development in a controlled manner.
• Define the process capability Cpk of critical assembly stations
• Responsible for determining OQ parameters to start validation.
• Commissioning of equipment including all necessary change controls and training.
• Sustaining Production Support
• Lead Continuous Improvement and optimizations of equipment on the floor to decrease variability and waste.
• 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.
• Provide new opportunity (sales) support:
• Conducts and/or participates in customer meetings. Interacts with Sales and customers to determine requirements for new products/orders.
• Define controls configurations for new device assembly business.
• Analyzes customer requests to determine equipment, tooling, or delivery systems needed, and fit with existing equipment and configuration management.
• Researches new trends and technologies in assembly automation and drug packaging; evaluates and tests new equipment and processes.
• Provide technical leadership/coaching to the engineering team.
• Be able to 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.

Education or equivalent:

• Bachelor of Science in Engineering and/or 5+ years of industry experienced required
• 5+ years relevant experience in assembly equipment installation, configuration programming, and configuration management
• Six Sigma Green Belt preferred
• Drug delivery device and/or drug-device combination product background preferred

Knowledge skills requirements:

• Coding on various platform PLCs, vision systems, robots, etc. are a must.
• Expertise with general industrial production equipment.
• 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 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.