Project Engineer

Join Our Team!

Ensera is looking for a motivated and collaborative Project Engineer (I–III) to join our growing team in Lakeland, Florida!

In this role, you will lead and support engineering projects from concept through implementation, ensuring projects are completed on time, within budget, and in compliance with quality and regulatory standards.

You will work closely with Manufacturing, Quality, Operations, customers, and external partners to develop new processes, improve existing operations, and support product launches in a regulated medical device and pharmaceutical manufacturing environment.

What You'll Do

• Lead and support engineering projects from planning through execution, validation, and implementation.
• Develop and improve manufacturing processes to increase efficiency, productivity, and product quality.
• Prepare and maintain project plans, timelines, validation protocols (IQ/OQ/PQ), and technical documentation.
• Collaborate with internal teams, customers, suppliers, and equipment vendors to ensure successful project execution.
• Support equipment selection, installation, qualification, and process improvements.
• Conduct design reviews, risk assessments, and supplier evaluations.
• Ensure compliance with FDA regulations, GMP, ISO 13485, and company quality standards.
• Provide technical support to manufacturing operations and troubleshoot production issues.
• Identify and implement continuous improvement opportunities.
• Monitor project progress, manage risks, and provide regular updates to stakeholders.

What We're Looking For

• Bachelor's degree in Engineering, Science, or a related technical field.
• 5+ years of engineering experience in a manufacturing environment.
• Experience in medical device, pharmaceutical, biotechnology, or other regulated manufacturing industries preferred.
• Knowledge of FDA regulations, GMP, ISO 13485, and equipment/process validation (IQ/OQ/PQ).
• Experience with process development, equipment validation, assembly, serialization, or pharmaceutical packaging is a plus.
• Strong project management, analytical, and problem-solving skills.
• Proficiency in Microsoft Office; experience with Minitab or similar statistical software preferred.
• Excellent communication and organizational skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Strong teamwork skills and a continuous improvement mindset.

Why Join Ensera?

At Ensera, you'll be part of a team dedicated to delivering high-quality manufacturing solutions for the medical device and pharmaceutical industries.

We offer a collaborative work environment where your ideas, expertise, and contributions make a difference. You'll have the opportunity to work on meaningful projects, develop your technical skills, and grow professionally.

Ready to make an impact?

We'd love to hear from you! Apply today and become part of the Ensera team.

Ensera is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all qualified applicants.