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.
Qualifications
* 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.
To start the process click the Continue to Application or Login/Register to apply button below.
#J-18808-Ljbffr