Role: Project Manager

Location: Murrysville, PA (Onsite)

Experience Required: 8+ Years

Job Summary:

We are seeking an experienced Project Manager to lead the transfer of our manufacturing line, ensuring compliance with regulatory standards in the medical products industry. This role requires a proactive leader who can navigate complex projects while maintaining a strong focus on quality, safety, and efficiency.

Key Responsibilities:

• Project Planning: Develop and implement a comprehensive project plan for the manufacturing line transfer, ensuring adherence to all regulatory and compliance requirements.
• Cross-Functional Coordination: Collaborate with engineering, quality control, regulatory affairs, and operations teams to facilitate a smooth and compliant transfer process.
• Timeline and Resource Management: Oversee project timelines, budgets, and resource allocation to ensure the successful transfer of the manufacturing line while prioritizing quality outcomes.
• Risk Management: Identify potential risks and challenges during the transfer process, and develop strategies to mitigate disruptions to ongoing operations.
• Compliance Oversight: Ensure all transfer activities comply with Good Manufacturing Practices (GMP), FDA regulations, and other relevant industry standards.
• Logistics Coordination: Work with supply chain and logistics teams to manage the transportation of equipment, materials, and products during the transfer.
• Stakeholder Communication: Provide regular updates to stakeholders and leadership on the progress of the manufacturing line transfer, addressing any concerns or challenges that may arise.
• Validation and Testing: Conduct comprehensive validation and testing of the transferred manufacturing line to ensure it meets all necessary quality standards for medical products.
• Documentation: Ensure all transfer activities are thoroughly documented, and that the new manufacturing line setup complies with all applicable standards and regulations.
• Team Leadership: Lead and support the project team to foster effective communication, collaboration, and successful execution of transfer activities.
• Skills: Strong communication, leadership, and problem-solving abilities, with demonstrated expertise in project management and medical product manufacturing.

Qualifications:

• Bachelor's degree in Management, Operations, Engineering, or a closely related field.
• PMP certification is a plus.