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Senior Validation Engineer
hace 2 meses
We are seeking a highly skilled Senior Validation Engineer to join our team at Validation & Engineering Group, Inc. The ideal candidate will have a strong background in validation engineering principles and practices, with experience in designing and implementing major system or process modifications and/or capital projects.
Key Responsibilities:
- Apply advanced validation engineering principles to the design and implementation of major system or process modifications and/or capital projects.
- Develop, organize, analyze, and present interpretation of results for operational issues or validation engineering projects of significant scope and complexity.
- Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.
- Develop validation engineering policies and procedures that affect multiple organizational units.
- Supervise, coordinate, and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
- Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.
- Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget, and quality constraints.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
Requirements:
- Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience.
- Biotechnology, Validation (Process, Cleaning, etc.), Manufacturing operations.
- Applies extensive technical validation expertise, and has full knowledge of other related disciplines.
- Provide technical solutions to a wide range of difficult problems.
- Solutions are imaginative, thorough, practicable, and consistent with organization objectives.
Competencies/Skills:
- In-depth knowledge of validation processes and requirements.
- Interacts effectively with variety of communication and working styles.
- Ability to independently determine when additional internal resources are required to solve problems.
- Ability to handle multiple projects at one time.
- Demonstrated Skills in the following areas: schedule development, facilitation, collaboration.
- Basic project management.
- Completion and follow-up.
- Technical expertise areas of validation engineering.
- Ability to independently determine when additional external resources are required to solve problems.
- Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
- Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
- Working knowledge of financial analysis tools.
- Ability to delegate and manage the project work of others.
- Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation, collaboration, project cost development, conflict resolution, decision making, leadership and teambuilding, management of contractors and vendors.
Availability:
- Available to work extended hours, possibility of weekends and holidays.
