Overview
Project Engineer Jobs in Lakeland, FL at Ensera
Title: Project Engineer
Company: Ensera
Location: Lakeland, FL
We're looking for a driven and collaborative Project Engineer (I–III) to join our growing team. In this role, you'll lead and support engineering projects from concept through implementation, ensuring projects are delivered on time, within budget, and in compliance with quality and regulatory requirements.
You'll work cross-functionally with Manufacturing, Quality, Operations, and external partners to develop new processes, improve existing operations, and support the successful launch of products in a highly regulated medical device and pharmaceutical manufacturing environment
.
What You'll
- DoLead and support engineering projects through planning, execution, validation, and implementatio
- n.Develop, optimize, and validate manufacturing processes to improve quality, efficiency, and productivit
- y.Create and maintain project plans, timelines, validation protocols (IQ/OQ/PQ), technical documentation, and engineering report
- s.Collaborate with internal teams, customers, suppliers, and equipment vendors to ensure successful project executio
- n.Support equipment selection, installation, qualification, and continuous process improvement
- s.Perform design reviews, risk assessments, and supplier evaluations while ensuring compliance with FDA, GMP, ISO 13485, and company quality standard
- s.Provide technical support to manufacturing operations and troubleshoot production issue
- s.Drive continuous improvement initiatives that enhance product quality, manufacturing efficiency, and on-time deliver
- y.Manage project risks, change requests, and progress reporting throughout the project lifecycl
e.
What We're Looking
- ForBachelor's degree in Engineering, Science, or a related technical fie
- ld.5+ years of engineering experience in a manufacturing environme
- nt.Experience within the Medical Device, Pharmaceutical, Biotechnology, or regulated manufacturing industry preferr
- ed.Knowledge of FDA regulations, GMP, ISO 13485, validation activities (IQ/OQ/PQ), and quality syste
- ms.Experience with process development, equipment validation, serialization, assembly, or pharmaceutical packaging is highly desirab
- le.Strong project management, analytical, and problem-solving skil
- ls.Proficiency with Microsoft Office and statistical software such as Minit
- ab.Excellent communication skills with the ability to manage multiple priorities in a fast-paced environme
nt.
Why Join
Us?At Ensera, you'll have the opportunity to work on innovative projects that support the medical device and pharmaceutical industries while collaborating with talented professionals committed to quality, continuous improvement, and operational excellence. If you're looking to make an impact in a growing organization, we'd love to hear from
you.
