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.

 

Key Responsibilities

• Lead end-to-end execution of packaging-related projects, including planning, scheduling, budgeting, coordination, and implementation.

• Coordinate activities across Packaging Operations, Engineering, Validation (CSV/CQV), Automation, Manufacturing, and Facilities to ensure successful project execution.

• Manage packaging equipment installation, upgrades, modifications, integration, and startup activities.

• Develop and maintain detailed project plans, schedules, resource plans, and risk mitigation strategies for packaging initiatives.

• Ensure compliance with cGMP regulations, safety requirements, internal procedures, and quality standards throughout all project phases.

• Oversee commissioning, qualification, and validation activities (IQ/OQ/PQ) associated with packaging equipment and systems.

• Coordinate change control activities, impact assessments, technical documentation, and implementation plans.

• Support packaging process improvements, operational readiness activities, and efficiency initiatives.

• Serve as the primary point of contact between clients, vendors, contractors, and cross-functional internal teams.

• Monitor project performance, budgets, deliverables, and KPIs while providing regular project status updates to leadership.

• Identify and resolve project risks, operational challenges, scheduling conflicts, and resource constraints.

• Support audits, inspections, and maintain projects in a state of compliance and inspection readiness.

Minimum Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related discipline required).

• Minimum of 5+ years of project management experience within pharmaceutical, biotechnology, or medical device industries.

• Proven experience supporting packaging operations, packaging equipment, serialization, labeling systems, inspection systems, or manufacturing support projects.

• Strong knowledge of cGMP regulations and pharmaceutical packaging operations.

• Hands-on experience with Commissioning, Qualification, and Validation (CQV) activities related to packaging systems and equipment.

• Experience managing Change Control systems within regulated manufacturing environments.

• Experience coordinating vendors, contractors, packaging equipment manufacturers, and cross-functional project teams.

• Strong leadership, organizational, communication, and problem-solving skills.

• Bilingual communication skills (English and Spanish preferred).

• Proficiency in MS Office applications including Word, Excel, PowerPoint, and Microsoft Project.

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.