Project Manager
mîrus Consulting Group View all jobs
- Gurabo, PR
- Permanent
- Full-time
- Lead end-to-end project execution, including planning, scheduling, budgeting, and delivery of engineering and operational projects.
- Coordinate activities across Manufacturing, Packaging, Validation (CSV/CQV), and Facilities/Utilities to ensure seamless project integration.
- Develop and maintain detailed project plans, timelines, and risk mitigation strategies.
- Ensure compliance with cGMP regulations, internal procedures, and quality standards throughout all project phases.
- Oversee commissioning, qualification, and validation activities (IQ/OQ/PQ), ensuring proper documentation and execution.
- Manage change control processes, including impact assessments, documentation, and implementation.
- Serve as the primary point of contact between internal stakeholders, clients, and cross-functional teams.
- Monitor project performance and provide regular status updates, reports, and KPIs to leadership.
- Identify and resolve project risks, issues, and resource constraints in a timely manner.
- Support audits, inspections, and ensure projects remain in a state of compliance and readiness.
- Bachelor’s Degree in Engineering (Mechanical, Electrical, Chemical, or related discipline required).
- Minimum of 5+ years of experience in a regulated industry (pharmaceutical, biotechnology, or medical devices).
- Proven experience managing projects across manufacturing, packaging, validation, and facilities/utilities.
- Strong knowledge of cGMP regulations and industry best practices.
- Hands-on experience with Commissioning, Qualification, and Validation (CQV) processes.
- Experience managing Change Control systems within regulated environments.
- Strong leadership, organizational, and cross-functional coordination skills.
- Excellent communication skills (English and Spanish preferred), both written and verbal.
- Proficiency in MS Office tools (Word, Excel, PowerPoint, Project)