The Role
Lead and manage process development projects across functions (manufacturing, engineering, QA, validation). Ensure cGMP compliance, regulatory adherence, documentation, risk mitigation, resource allocation, and continuous improvement using Lean Six Sigma and operational excellence. Support business cases, timeline management, and flexible shift coverage to meet project goals.
Summary Generated by Built In
Specific responsibilities include but are not limited to:
• Support all phases of inspection project management—from planning and implementation to monitoring, completion, and follow-up—ensuring 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 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.
Requirements
Doctorate PhD + 2 years of Scientific or Engineering experience
OR Masters + 5 years of Scientific or Engineering experience
OR Bachelors + 7 years of Scientific or Engineering experience.
Skills Required
- Doctorate (PhD) plus 2 years scientific or engineering experience OR Masters plus 5 years OR Bachelors plus 7 years
- Knowledge and adherence to cGMP procedures and documentation requirements
- Experience with process validation and validation activities
- Experience applying Lean Six Sigma, operational excellence, or continuous improvement methodologies
- Project management experience including planning, resource allocation, timeline tracking, and risk mitigation
- Ability to work cross-functionally with manufacturing, process engineering, maintenance, QA, and validation
- Willingness/flexibility to support extended hours, non-standard shifts, weekends in a 24/7 format
- Ability to develop technical and financial business cases and implement project strategies
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The Company
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
