Automation Project Manager

Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. 

Essential Responsibilities:

1. Project Management
   • Develop, manage, and maintain project schedules, ensuring timely completion of deliverables.
   • Track budgets and expenses, ensuring cost adherence and flagging deviations.
   • Generate regular project status reports for stakeholders and leadership.
   • Ensure proper resource allocation and manage project priorities.
2. Change Management and Documentation
   • Lead and generate change notifications, ensuring full compliance with documentation systems and processes.
   • Present change proposals in regulatory forums and ensure approvals are obtained.
   • Develop and route project-related documents through the change management system for formal approval.
   • Participate in required trainings on change management and documentation systems.
3. Coordination of Activities
   • Facilitate cross-functional team meetings to ensure alignment on project goals and timelines.
   • Serve as the main point of contact for internal teams and external vendors, ensuring smooth execution of project activities.
   • Coordinate with validation, automation, and quality teams to ensure project deliverables comply with procedures, medical device regulations and standards.
4. Regulatory and Compliance
   • Ensure projects adhere to medical device industry standards and regulatory requirements.
   • Attend regulatory meetings/forums to represent project changes and provide updates as needed.
5. On-Site Responsibilities
   • Be physically present at the manufacturing site to monitor project progress and ensure alignment with production and automation needs.
   • Provide hands-on support for troubleshooting and issue resolution related to project scope.
6. Technical Knowledge
   • Apply general knowledge with development lifecycles for industrial automation and software engineering.
   • Collaborate with automation and controls teams to align on system integration strategies.

Required Qualifications:

• Education: Bachelor’s degree in engineering, Industrial Automation, or related field.
• Experience:

• 3- 5 years of experience managing software and industrial automation projects, preferably in a medical device manufacturing environment.
• Knowledge of medical device regulatory requirements.

• Skills:

• Proficiency in project management tools (e.g., MS Project, Smartsheet).
• Familiarity with industrial automation systems (Rockwell, Siemens, Cognex, etc.).
• Experience with change management systems and document control processes.
• Strong organizational, communication, and leadership skills.
• Ability to manage multiple projects and priorities simultaneously.

Additional Requirements:

• On-site presence is required.
• Ability to attend and complete internal trainings on change management and documentation systems.
• Experience working in regulated environments with focus on quality and compliance.

Work Environment:

• The role is based on-site in a manufacturing plant environment and requires close coordination with engineering, automation, production, quality, and compliance teams. Occasional travel may be required for vendor coordination or regulatory meetings.