Sr. Engineer

mîrus Consulting Group View all jobs

Juncos, PR
Permanent
Full-time

30 days ago

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.

mîrus Consulting Group

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