Project Manager

Mandatory Language skills : Spanish

Remote working

Key Responsibilities

• Project Planning & Execution: Define project scope, goals, and deliverables in collaboration with senior management and stakeholders. Create comprehensive project plans, including resource allocation, milestones, and timelines.
• Budget & Resource Management: Forecast requirements, manage project budgets, track expenses, and mitigate variances.
• Team Leadership: Lead and motivate cross-functional teams, delegating tasks effectively to ensure accountability and high performance.

• Risk Management: Proactively identify potential risks, issues, and bottlenecks, developing contingencies to resolve problems quickly.

• Stakeholder Communication: Serve as the primary point of contact for stakeholders, providing regular status updates, reports, and performance metrics.
• Quality Assurance & Closeout: Ensure all project deliverables meet quality standards and organizational goals. Conduct post-project evaluations to identify areas for future improvement

• Compliance & Validation: Direct software validation processes, ensuring all MES applications adhere to FDA 21 CFR Part 11 (electronic records and signatures) and Good Automated Manufacturing Practice (GAMP) standards.

• Shop Floor Integration: Manage the .NET-based software architecture connecting plant floor hardware (PLCs, SCADA) to enterprise-level ERPs to track production metrics and genealogy.
• Cross-Functional Leadership: Lead software engineers, automation experts, and quality assurance teams through Agile or hybrid SDLC methodologies.

• Risk Management: Enforce cybersecurity and data integrity protocols specific to medical manufacturing, maintaining audit trails for device history records (DHR).

Expected Qualifications

• Technical Stack: Strong proficiency in C#, , .NET Core, SQL Server, and WPF or Blazor for HMI/dashboard development.
• Domain Expertise: Direct experience managing MES implementations within Life Sciences or Medical Devices (Class II/III).
• Certifications: PMP (Project Management Professional) or Certified Scrum Master (CSM), coupled with deep knowledge of Quality Management Systems (QMS).

• Regulatory Knowledge: Familiarity with ISO 13485 and FDA design controls

• Strict Validation (CSV): Computer Software Validation is mandatory. Every configuration must be meticulously documented and proven to perform as intended.
• eDHR (Electronic Device History Records): Transitioning from paper records to an eDHR system, requiring deep coordination between IT, quality assurance, and manufacturing operators.