Clean Room Project Manager

Clean Room Project Manager

Our client is a leading provider of packaging solutions, operating in a controlled cleanroom environment. We are seeking an experienced Clean Room Project Manager to oversee the smooth and efficient operation of two cleanroom production lines dedicated to medical device packaging. This role offers a unique opportunity for someone with a solid engineering background and a keen eye for process optimization to make a significant impact on production quality and compliance.

The ideal candidate will bring extensive cleanroom experience, especially in medical device packaging or related industries such as pharmaceuticals and plastics. As the Clean Room Project Manager, you will be responsible for overseeing day-to-day operations within the cleanroom, ensuring strict adherence to industry standards, and managing both projects and teams to meet production goals and quality standards.

This Role Offers:

Competitive pay, plus comprehensive benefits including health/dental/vision, 401K matching, etc.

Stable company with decades of experience developing and producing top of the line packing products.

Lean, efficient manufacturing environment.

High degree of freedom to refine operational and manufacturing processes.

Company prioritizes sustainability efforts and environmental impact.

Focus:

Oversee daily operations of cleanroom production lines, ensuring compliance with ISO, FDA, and medical device packaging standards.

Manage cleanroom environment control, sanitation, and safety procedures to maintain product quality.

Lead cleanroom team, providing training, guidance, and ensuring adherence to best practices.

Oversee medical device packaging validation and collaborate with cross-functional teams on process improvements.

Drive continuous improvement initiatives, optimizing production efficiency and reducing waste.

Manage project timelines, resources, and budgets to meet production goals and deadlines.

Conduct audits of cleanroom processes and equipment, addressing any issues or inefficiencies.

Monitor and control operational costs, ensuring resources are utilized effectively.

Skill Set:

Bachelor’s degree in relevant engineering field.

5+ years of experience in cleanroom manufacturing or medical device packaging, with at least 3 years in a management role.

Strong knowledge of cleanroom operations, ISO 13485, FDA regulations, and medical device validation.

Experience in plastics manufacturing or molding operations is a plus.

Proven leadership skills with a focus on process improvement and team development.

Excellent problem-solving and analytical abilities.

Proficiency in Microsoft Office and project management software.

Ability to interpret technical specifications, blueprints, and schematics.