Prinicipal Operational Excellence Engineer
Location:
West Chester , Ohio
Posted:
November 24, 2017
Reference:
R-016929
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a Principal Operational Excellence Engineer you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
In this position, you will champion Lean activities to systematically eliminate waste, non-value-added activity, and reduce process variation. It will be your mission to generate excitement and engage everyone at the plant in Lean culture and principles.  You will guide people as they embrace Lean and commit to new ways of thinking and working.
Essential Job Functions:
  • Complete required training.
  • Perform visual inspections.
  • Lead and coordinate investigations and studies with little supervision.
  • Lead process improvement activities and teams to meet strategic goals.
  • Use SAP to track inventory and materials.
  • Facilitate communication between management and non-management.
  • Facilitate team meetings to discuss progress, initiatives, and/or other matters.
  • Provide leadership, development, and mentoring for others.
  • Supervise day to day activities of others.
  • Develop lean processes and procedures.
  • Identify temporary and permanent fixes to address issues.
  • Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
  • Facilitate inter-departmental meetings to discuss matters involving the coordination of multiple departments.
  • Coordinate with representatives from other departments.
  • Interact with other departments to implement corrective/preventative actions.
  • Participate in cross-functional teams to meet strategic goals.
  • Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
  • Monitor and analyze process equipment performance.
  • Assess and implement improvements in productivity, waste generation, quality and cost.
  • Assign work tasks and activities to others.
  • Lead committees or groups of employees tasked with accomplishing some objective(s).
  • Create new process modifications.
  • Represent the site in organization-wide projects and meetings.
Other Duties:
  • Prepare documentation of activities, actions, and/or results.
  • Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
  • Ensure proper documentation practices during job activities.
  • Conduct troubleshooting activities.
  • Train others on systems, software, equipment, machines, procedures, and/or processes.
  • Answer compliance and process questions from others.
  • Communicate policies and procedures to employees.
  • Establish visual tracking and other tools to enhance Audit readiness and trend analysis.
  • Fill in for immediate supervisor when absent.
  • Gather, organize, and communicate operational information to others.
  • Communicate priorities and progress to team on a continuing basis.
  • Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions.
  • Assist with coordinating activities of support groups.
  • Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.
  • Monitor key performance indicators to meet strategic goals.
  • Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
  • Write, review, and revise SOPs (Standard Operating Procedures) for maintenance of equipment, systems, and/or facilities.
  • Lead and make final decisions regarding hiring (for example: conduct interviews, evaluate candidates).
  • Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
  • Manage the performance of others, including performance/merit reviews, professional development, and disciplinary action.
  • Approve new and updated SOPs.
  • Attend team meetings to discuss progress, initiatives, and/or other matters.
  • Collect, record, and report metrics.
  • Monitor equipment and/or systems for performance and problem indicators.
  • Perform data entry.
  • Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, etc.
  • Report process deviations when they occur.
  • Read and interpret diagrams, drawings, and other schematics.
  • Conduct safety checks for work group, department, or site.
  • Conduct presentations (other than training) for different audiences.
  • Develop and communicate a vision for the function in alignment with overall organizational goals.
  • Examine safety and ergonomic issues on the line.
  • Lead teams in root cause analysis sessions.
  • Prepare regular and ad hoc reports for others.
  • Present validation information to operational excellence leadership team.
  • Track corporate quality KPIs (Key Performance Indicators).
Minimum Requirements:
4-year degree in Engineering or technical discipline and 7 years of experience leading lean initiatives within a regulated or cGMP environment.  Strong project management experience.
Preferred Requirements:
IASSC Certified Lean Six Sigma Black Belt.
Essential Mental Functions:
  • Perceiving Information with Speed and Accuracy
  • Following Instructions
  • Communicating Orally
  • Learning New Knowledge and Skills
  • Generating Creative Ideas
  • Making Decisions
  • Reasoning and Thinking Critically
  • Solving Problems
  • Troubleshooting
  • Multi-Tasking
  • Perceiving Meaning and Messages
  • Memorizing
  • Concentrating
  • Analyzing and Understanding Systems
  • Performing Basic Mathematical Calculations
  • Using Mathematics to Solve Problems
  • Reading and Understanding Written Information
  • Reading and Understanding Technical Information
  • Communicating in Writing
  • Visualizing Objects
  • Using Tables, Charts, and Graphics
  • Working with Data
  • Analyzing Data
  • Using Correct Spelling and Grammar
  • Thinking Strategically
Equipment Used-
               Copier
  • Printer
  • Desktop computer
  • Laptop computer
  • Desk phone
  • Cell phone
Required Competencies:
  • Achieving Work Goals
  • Focusing on the Mission
  • Acting with Integrity
  • Adhering to Work Schedules
  • Striving for Improvement
  • Working Hard
  • Overcoming Obstacles
  • Resolving Work Problems
  • Following Through on Commitments
  • Selectively Detaching from Work
  • Maintaining Order
  • Planning Actions
  • Following Rules and Procedures
  • Working Safely
  • Attending to Details
  • Managing Own Time
  • Maintaining Accountability
  • Working with Others
  • Cooperating with Others
  • Relating to Others
  • Listening to and Understanding Others
  • Dealing with Interpersonal Conflicts
  • Serving and Helping Others
  • Remaining Calm and Even Tempered
  • Demonstrating Optimism
  • Exhibiting Liveliness
  • Acting Professionally
  • Demonstrating Self-Confidence
  • Taking Charge
  • Influencing Others
  • Understanding Others' Perspectives
  • Delegating to Others
  • Supporting Diversity
  • Adapting to Changing Methods or Priorities
  • Performing Repeated Tasks
  • Performing Varied Tasks
  • Organizing, Planning, and Prioritizing Work
  • Understanding Mechanical Principles
  • Repairing and Maintaining Mechanical Equipment
  • Repairing and Maintaining Electronic Equipment
  • Providing Consultation and Advice to Others
  • Interacting with Computers
  • Using Technology to Complete Work
  • Entering Data and Information
  • Gathering Information
  • Measuring Objects
  • Estimating
  • Training or Instructing Others
  • Managing Others
  • Taking Direction
  • Focusing on Success
  • Taking Pride in One's Work
  • Championing Change
  • Developing and Building Teams
  • Identifying Talent
  • Establishing Vision
  • Developing Objectives and Implementation Strategies
  • Knowledge of Assembly Operations
  • Knowledge of Blueprint Reading
  • Knowledge of cGMP (Good Manufacturing Practices)
  • Knowledge of Engineering and Technology
  • Knowledge of Microsoft Office
  • Knowledge of Metrology
  • Knowledge of EDMS
  • Knowledge of LMS

A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca

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