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.

Position Overview
Senior Engineer responsible for providing technical leadership and support in:

• Process validation
• Packaging systems characterization
• Product transfer activities

Supports Drug Product & Packaging operations ensuring:

• GMP compliance
• Proper validation lifecycle execution
• Equipment and process robustness

Core Responsibilities
Validation & Engineering

• Execute and lead:
  • Commissioning / Qualification (IQ/OQ/PQ)
  • CSV activities
• Develop and execute:
  • Validation protocols
  • Characterization studies
• Author/review:
  • Validation reports
  • Technical documentation
• Support:
  • Process characterization
  • Equipment performance evaluation
  • PPQ execution

Packaging & Process Support

• Provide technical support for:
  • Packaging equipment
  • Labeling systems
  • Device assembly
• Evaluate:
  • Automation systems
  • Vision inspection
  • Serialization and labeling
• Troubleshoot:
  • Packaging processes
  • Equipment issues
• Support:
  • Technology transfer
  • New Product Introduction (NPI)

Documentation & Compliance

• Author and execute:
  • Protocols
  • Validation reports
  • Technical assessments
• Manage:
  • Change controls
  • Impact assessments
• Investigate:
  • Deviations
  • CAPAs
• Ensure compliance with:
  • GMP
  • FDA regulations
  • Internal quality systems

Cross-Functional Collaboration

• Work with:
  • Manufacturing
  • Quality
  • Automation
  • Engineering
• Participate in:
  • Risk assessments (FMEA)
  • Regulatory inspections and audits
• Provide:
  • Technical guidance
  • Training support

Additional Responsibilities

• Drive continuous improvement initiatives
• Analyze process performance data
• Support:
  • Equipment upgrades
  • Engineering projects
• Align with:
  • Validation Master Plan
  • Lifecycle validation strategy

Basic Qualifications

• Bachelor’s Degree in:
  • Mechanical Engineering
  • Electrical Engineering
• Minimum of 4 years of experience in pharmaceutical or biotechnology industry

Preferred Qualifications

• Experience with:
  • Packaging equipment
  • Manufacturing processes
• Strong knowledge of:
  • Validation lifecycle
  • GMP and FDA regulations
• Experience in:
  • Technology transfer
  • Product launches
  • Process improvement initiatives
• Experience writing:
  • Validation protocols and reports
  • Change controls
  • Deviation investigations
• Familiarity with:
  • Automation systems
  • Serialization
  • Vision inspection technologies

Key Technical Skills

• Process Characterization
• Validation Lifecycle (IQ/OQ/PQ / PPQ)
• Packaging Equipment Engineering
• Change Control and Deviation Management
• Technical Writing (Protocols and Reports)
• GMP and FDA Compliance
• Risk Assessments (FMEA)
• Root Cause Analysis

Role Impact
Ensures robust process validation, successful product transfers, and reliable packaging operations, supporting the delivery of high-quality pharmaceutical products.

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.
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