26th March, 2020
Contract for Project Engineer - Must have Validation, FDA and QA experience. Certification is preferred.
Work will be remote, servicing the following areas:
West Point, PA will be client home base
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To lead, manage, and provide planning and execution direction in multiple, variable scale Computer System Validation and Instrument Qualification Projects on a global basis, while contributing in process development, improvement and implementation, as well as new business development support. Cross training for all other One Source Professional Services projects expected.
Manage and drive quality, objectives, planning, and implementation of the projects .
Ensure quality of project documents based on project and business requirements. Setting timelines, milestones and assurance that business requirements are met.
Monitor progress of activities and budget against project plan. Determine and ensure appropriate action upon critical path tasks.
Drive decision making, inside and outside of the team. Identify and ensure resolution of conflicts and problems.
Continuously seek process improvement. Ensure quality and compliance throughout the development process.
Ensure scope consistency of project throughout the development process.
Establish agreed risk management plan.
Establish and maintain clear communication channels to provide full transparency throughout the project.
Establish and lead the internal operational team and customer facing operational team of project stakeholders to meet, review, and report on all aspects of project specific action items.
Adherence to all relevant regulations and guidelines.
Assign projects to Computer Validation resources.
Provide leadership to Computer Validation resources.
Ensure that Computer Validation resources are equipped with the proper training to execute the project tasks.
•Bachelor’s degree in Science or Business Management; Master’s in Business Management preferred.
•PM certification (CAPM, PMI, PMP, PRINCE2) recommended. Mandatory after 1 year in position.
•Minimum of 3-5 years in an FDA regulated industry, particularly in a Quality Assurance department, preferred
•Experience with SDLC, system validation, instrument qualification a plus
•Project Management or Process Development experience.
•Highly organized and motivated. Must be able to work in a fast paced environment, with high attention to detail.
•Excellent communication skills, experience with customer interaction.
•Ability to influence cross functional teams and various levels of professionals.
•Proven operational strength to visualize, identify and implement processes.
•Demonstrated leadership qualities with a strong bias for action.