Job Description

Must Haves:

• Bachelor’s degree in Engineering, Project Management, Business Administration, or a related field.
• 2+ years of experience in project scheduling
• Proficiency in Microsoft Project
• Strong understanding of validation processes, regulatory requirements, and quality standards.
• Excellent communication and organizational skills.
• Ability to work in a fast-paced, deadline-driven environment.
• Experience with Lean Manufacturing, Six Sigma, or Agile methodologies

Pluses:

• Master's Degree or PMP Certification
• Experience in medical device manufacturing or a regulated industry
• Smartsheet

Job Summary:

We are seeking a Project Scheduler to support the expansion of our medical device manufacturing facility. This role will work closely with Validation Engineers to develop and maintain project schedules, ensuring timely execution of validation activities, regulatory compliance, and seamless integration of new systems within the expanded site.

Key Responsibilities:

• Collaborate with Engineering personnel to align project schedules with validation protocols and regulatory requirements.
• Develop and maintain detailed timelines for site expansion activities, including equipment installation, commissioning, and qualification.
• Track progress, identify potential delays, and implement corrective actions to keep the expansion on schedule.
• Ensure compliance with FDA, ISO, and GMP regulations throughout the validation process.
• Coordinate with cross-functional teams (engineering, quality assurance, operations) to ensure smooth execution of expansion plans.
• Utilize Microsoft Project to create, update, and analyze project schedules.
• Experience with Smartsheet is preferred for enhanced project tracking and collaboration.
• Prepare reports and presentations on project milestones, risks, and resource allocation.
• Support risk management efforts by identifying scheduling conflicts and proposing solutions.

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