Process Development Principal Scientist

We are seeking a Process Development Principal Scientist to support all phases of inspection project managementfrom planning and implementation to monitoring completion and follow-upensuring alignment with goals timelines and quality standards.

• Lead PD related Project Management projects and activities timelines and resources allocation.
  
• Work in teams with multiple fields including manufacturing process engineering maintenance quality assurance and validation to implement projects.
  
• Support the development of comprehensive business cases including technical and financial requirements.
  
• Identify potential project risks schedule changes or resource constraints. Develop and implement solutions to maintain scientific efficiency quality and client satisfaction.
  
• Maintain strict adherence to domestic and international regulatory requirements internal policies and standard operating procedures throughout the project lifecycle.
  
• Balance competing timelines and priorities ensuring critical tasks are completed efficiently and project standards for quality and quantity are met.
  
• Provide flexibility to support extended hours non-standard shifts and evolving project demands as needed.
  
• Ensure activities follow cGMP procedures and are documented according to cGMP requirements including assigned training.
  
• Independently evaluate select and apply standard engineering techniques and procedures.
  
• Perform assignments that have clear and specific objectives and require investigation of a limited number of variables.
  
• Applies lean six sigma operational excellence and continues improvement in assigned projects.
  
• Prompt and regular attendance to workplace. Although main working hours are regular 8:00 am to 5:00 pm the candidate need the flexibility to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.
  
• Meet specific project team goals and timelines.
  
• Develop project plans and strategies for implementation working with project managers and SMEs.