Senior Computer System Validation Csv Jobs in Bayamon, PR

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

The Senior Project Manager, is responsible for leading strategic and highly complex New Product Introduction (NPI) programs within a regulated manufacturing environment. This role provides leadership throughout the project lifecycle, from project initiation and planning through commercialization and operational readiness, ensuring successful execution of business objectives while maintaining compliance with quality and regulatory requirements.

• Lead strategic and highly complex New Product Introduction (NPI) programs from concept through commercialization and lifecycle management.
• Develop and execute project strategies that align with organizational goals and business objectives.
• Provide project governance and oversight across multiple functional areas, including Manufacturing, Engineering, Quality, Supply Chain, Procurement, Regulatory, and Operations.
• Drive organizational alignment and facilitate decision-making among stakeholders and leadership teams.
• Ensure operational readiness and successful technology transfer, startup, and product launch activities.
• Identify, assess, and proactively manage project risks, issues, dependencies, and mitigation plans.
• Lead the planning, execution, monitoring, and closure of multiple complex projects and programs.
• Develop and manage project schedules, budgets, resource plans, and project deliverables.
• Coordinate cross-functional teams and stakeholders in a matrix environment to achieve project objectives.
• Monitor project performance and communicate project status, milestones, risks, and key performance indicators to leadership.
• Facilitate governance meetings, steering committee reviews, and executive project updates.
• Drive Change Control activities and ensure compliance with applicable quality systems and regulatory requirements.
• Support procurement, sourcing, contracting, and vendor management activities as required.
• Prepare executive-level presentations, reports, business cases, and strategic recommendations.
• Champion continuous improvement initiatives and share project management best practices across the organization.
• Provide leadership, mentorship, coaching, and strategic direction to project team members and stakeholders.
• Influence senior leadership and drive alignment on critical business decisions impacting project execution and commercialization efforts.

• Doctorate + 2 years of Project Management experience OR
• Masters + 4 years of Project Management experience OR
• Bachelors + 6 years of Project Management experience

Candidates with the following qualifications will stand out:

• Experience leading New Product Introduction (NPI), Product Transfers, Technology Transfers, or Commercialization Programs in pharmaceutical, biotechnology, medical device, or highly regulated manufacturing environments.
• Demonstrated success managing large-scale, high-visibility, cross-functional projects with significant business impact.
• Experience supporting product launch readiness, manufacturing readiness, and commercialization strategies.
• Working knowledge of Ariba Sourcing and Contracting Modules.
• Experience utilizing SAP, TrackWise, and project portfolio management tools.
• Strong understanding of project governance, risk management, and change management methodologies.
• Experience presenting to and influencing executive leadership teams.
• Proven ability to mentor project managers and lead teams within a matrix organization.

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.