GerTEK is an engineering consultancy company.
We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects.
Purpose: The Project Engineer is responsible for safely coordinating and leading projects associated with Process Improvements, Automation, Aseptic processing, New Processing equipment with some Facility / utilities modifications to incorporate same.
The primary responsibility of the role is to ensure that Projects meet their agreed goals/targets on time and on budget.
Responsibilities Led and manage multiple aseptic cleanroom projects from conception to completion, adhering to strict regulatory and quality standards.
Collaborate closely with cross-functional teams, including architects, facility engineers, and quality assurance personnel, to ensure successful execution of projects.
Develop detailed project plans, timelines, and budgets, ensuring effective utilization of resources and timely delivery of projects.
Oversee the procurement of equipment, materials, and services, ensuring compliance with project specifications.
Monitor project progress, identified potential issues, and implemented corrective actions to ensure projects stayed on track.
Coordinate with external contractors and vendors, ensuring adherence to project requirements and specifications.
Conduct regular inspections and audits to ensure compliance with cleanroom standards and regulatory guidelines.
Prepare comprehensive project documentation, including reports, progress updates, and final project summaries.
Led equipment FAT/SAT on process equipment and coordinate the engineering aspects of qualification.
Become the engineering SME for the project and process.
So, what education & experience do you need for this role?
5+ year's experience in working within the pharmaceutical manufacturing, medical device or similar industry Bachelor of Science/Engineering in Mechanical /Process Engineering or equivalent discipline.
Excellent problem-solving and critical thinking abilities.
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