Job Summary

Responsibilities include using technical expertise in support of daily operations in aseptic filling or formulation by defining, measuring, analyzing, coordinating, implementing and follow-up concerning projects and activities designed to increase or improve safety, quality, productivity, and/or capacity. Apply accepted engineering practices and project management techniques to assigned daily tasks and projects. Analyze situations, break them down into key components and milestones, conduct fact-finding missions, provide detailed plans of action, and implement plans as assigned.

• Develops systems to identify and measure key performance indicators (uptime, downtime, scrap, yield).
• Identifies key site capacity constraints and provides timely solutions to resolve.
• Uses Lean tools to measure, understand, and improve process variability and efficiency.
• Manages related capital projects adhering to budget and schedule constraints.
• Provides on-going technical support for manufacturing operations in aseptic filling or formulation.
• Analyzes daily production and processing problems, identifies and implement shop-floor continuous improvement projects.
• Establishes engineering tracking tools and enforce their usage through fact driven communication between all stakeholders (e.g., operations, maintenance, quality, engineering, technology center, suppliers, etc.).
• Coordinates maintenance and drive technical activities for cGMP compliant manufacturing improvement
• Works with production personnel to establish or revise work instructions and procedures used in the production environment.
• Ensures timely completion of the tasks and support as assigned by management.
• Maintains awareness of current pharmaceutical manufacturing needs and standards and communicates possible programs/projects to achieve the goal of facility being a state-of-the-art pharmaceutical manufacturing site.
• Coordinates activities of various vendors for projects to eliminate any potential conflict and assures that vendors comply with all the safety rules and regulations.
• Prepares URS, Risk Assessments, Safety Assessments associated with the support of and execution of projects.
• Prepares specifications for projects to include all dimensions, electrical, HVAC and mechanical considerations.
• Works effectively with Operations and Quality to ensure project results are compliant with site and industry regulations and guidelines.
• Responsible for maintaining and constant improvement of the ISO 50001 energy management system.
• Identify energy savings opportunities and make recommendations to achieve more energy efficient operation.
• Monitor and analyze energy consumption.

• Bachelor’s degree in Engineering (Electrical, Chemical, Controls, Computer, Mechanical, etc.).
• 1-3 years plant manufacturing experience.
• Understanding of control systems and PLC programming of highly automated manufacturing technologies (Siemens/Allen Bradley).
• Understanding of S88 standard batch programming (PCS7, Plant PAX, Delta V) preferred.
• Ability to coordinate and support contractors or team members as assigned.
• Excellent verbal and written communication skills (technical writing and presentation)
• Working knowledge of AutoCAD or SolidWorks preferred.
• Must be able to work independently and set priorities.

Additional Information