Job Description

Job Description

Job Description

Position Summary

This person will be responsible for managing process improvements, troubleshooting, and developing corrective and preventative actions. Coordinating, evaluating, and leading engineering projects in the manufacturing facility, with special emphasis on equipment evaluations and implementing solutions using engineering principles, advanced machinery and automation technologies and making recommendations for revision and standardizing of equipment. The goal is to deliver efficient, safe, high quality production output while minimizing unplanned downtime and waste.

General Expectations and Supervisory Responsibilities

• Coordinates and leads Process Improvement projects which pertain to all phases of the sterile fill manufacturing process.
• Highly organized, self-motivated and independent worker with strong skills in change, problem solving, communication, customer orientation, team skills and quality.
• Identify, design and implement manufacturing aids (fixtures, jigs, tools, etc.) to reduce manufacturing costs associated with direct labor, scrap and rework.
• Minimize quality issues and evaluate results; develop and improve manufacturing processes to meet customer and product requirements, introduce products into the production areas and follow products through the entire Manufacture, test, pack and ship process
• Lead and participating in multiple projects and project teams in the investigation, problem analysis, alternative evaluation and implementation of permanent solutions to chronic issues using data based solutions such as the use of lean problem solving techniques.
• Provide equipment technical assistance to operations personnel.
• Bring Best-in-Class techniques, procedures, processes and know-how into the plant operations: equipment, facilities, production processes with focus on analytical solutions.
• Maintain expertise on equipment with multiple degrees of freedom, manufacturing technology changes, and core process technologies
  • Support daily activities in Operations through staffing and flexible hours; remain on-call for critical operations
  • Work with manufacturing management to identify key areas of equipment and process improvement, then lead the implementation of these changes
  • Support validation activities including equipment validation through collaboration on protocols and aid in execution
  • Lead problem solving and investigations related to filling operations
  • Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Maintenance, Engineering, among others, to develop and maintain processes that meet cGMP and business requirements.
  • Provide construction management oversight for ongoing capital projects
  • Oversee contractors and service providers
  • Troubleshoot, repair and ensure PM functions are performed on equipment and building components as required and in compliance with all regulatory requirements, including maintaining records and reports
  • Utilize technical knowledge to assist in determining root cause of equipment or system failure and facilitate corrective actions
  • Prepare and receive work orders as required for repairs and PM contracts with vendors
  • Provide after-hours call-in support for production and utility outages, equipment breakdown and emergency events
  • Other duties as assigned

Regulatory Responsibilities

• Conduct business in a responsible manner that complies with all state and federal regulations, or otherwise as applicable
• Maintain a detailed and comprehensive understanding of USP, FDA, EU Annex 1, and other regulatory agency requirements
• Maintain qualification on filling operations by successful media fill simulation

Experience

• Five plus (5+) years' experience in aseptic processing, terminal sterilization or lyophilization desired
• In the absence of above, 5+ years of demonstrated excellence in related technical field, i.e. performing research, technical or field work utilizing scientific or industrial equipment.

Education

• Bachelor’s degree in Industrial, Chemical, Manufacturing, or Mechanical Engineering from an accredited college or university
• Equivalent experience may be substituted for educational requirement

Knowledge, Skills & Abilities

• Excellent technical writing skills
• Knowledge of engineering first principles
• Knowledge of parenteral drug product development and manufacturing
• Able to work in a dynamic environment and adapt to changing priorities
  • Excellence in solving complex engineering and / or scientific problems
• Expertise with Microsoft Office
• Familiar with Quality Management Systems
• Project management skills
• Attention to detail
• Oral communication skills

Physical Requirements

• Ability to meet gowning requirements
• Ability to remain stationary for prolonged periods of time
• Ability to periodically lift up to 50 lbs.
• Satisfactory audio-visual acuity

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