Project Manager

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.

Role Summary

The Project Manager provides vision and leadership to strategic projects with significant site impact. Ensure new products are launched from the site in alignment with contract goals. Manage the performance of projects or significant subsystems associated with new products by influencing, coordinating, and driving activities, initiatives, and development deliverables across cross-functional teams. Direct all phases of new product development projects from inception through completion from an Operations perspective. Lead project review sessions focusing on cost, schedule, and technical performance. Establish milestones, monitor adherence to plans and schedules, identify issues, and implement solutions. Ensure Value Improvement Projects (VIP) and new product initiatives are completed in alignment with contract expectations.

Key Responsibilities

• Project Planning & Definition: Define project goals, scope, resource and cost estimates, timeline, and risks. Facilitate cross-functional discussions to develop project proposals.
• People Leadership: Manage large, multi-project, multi-site cross-functional teams; provide performance input; foster strong alignment.
• Value Improvement (VIP): Oversee VIP initiatives; identify, communicate, and manage risks.
• Project / Program Management: Lead initiation, planning, execution, control, and close-out activities; ensure team ownership of plans, schedules, and budgets.
• Process Management: Ensure activities follow established processes; maintain documentation discipline; reinforce VIP and NPE best practices.
• Communications & Reviews: Drive cross-functional communication; serve as liaison between teams and leadership; lead phase reviews; maintain documentation including minutes, issue logs, and metrics.
• New Product Excellence (NPE): Implement NPE methods; manage NPE risks and deliverables.

Experience Requirements

• 5–7+ years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry (medical devices, pharmaceuticals, biotechnology, diagnostics, or similar).
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
• Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and process validation.
• Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems.
• Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.
• Familiarity with controlled documentation systems, engineering change processes, and manufacturing readiness requirements.
• Experience ensuring compliance with quality system procedures and regulatory expectations across the project lifecycle.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.