Quality & Validation Engineer

Stark Pharma Solutions Inc; Colorado; On-site; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical solutions company is seeking a Quality & Validation Engineer in Colorado. The ideal candidate will have over 3 years of experience in validation within a regulated environment. Responsibilities include authoring validation protocols, ensuring compliance with FDA and ISO standards, and collaborating with cross-functional teams. Strong technical writing and communication skills are essential for this role.

Qualifications

• Minimum 3 years of hands-on validation experience in a regulated environment.
• Proficiency in developing and executing IQ/OQ/PQ protocols.
• Strong knowledge of GMP, QSR, ISO 13485.

Responsibilities

• Author, execute, and review validation protocols.
• Ensure compliance with FDA, ISO 13485 standards.
• Support integration of new equipment and process modifications.

Skills

Validation Protocol Development

Regulatory Compliance

Risk Assessment (FMEA)

Technical Writing

Communication Skills

Education

Bachelor's degree in Engineering, Life Sciences, or a related technical field

Tools

TrackWise

Minitab

Job description

Overview

Job Title: Quality & Validation Engineer
Location: Lafayette, CO
Experience: 3+ years

We are seeking a skilled Quality & Validation Engineer to support validation activities across manufacturing processes, test systems, and equipment. This role is critical to ensuring compliance with FDA regulations, ISO standards, and internal quality systems. You\'ll collaborate closely with cross-functional teams including Engineering, Quality, and Production to drive validation projects from planning through execution.

Key Responsibilities

• Author, execute, and review equipment, process, and test method validation protocols (IQ/OQ/PQ)
• Ensure validation activities meet FDA, ISO 13485, and internal quality system standards
• Support integration of new equipment, process modifications, and continuous improvement projects
• Work with Quality, Manufacturing, and R&D teams to define validation requirements
• Perform risk assessments (FMEA), contribute to root cause analysis, and support CAPA implementation
• Prepare and maintain complete validation documentation, including traceability and change control records
• Act as subject matter expert during audits and regulatory inspections

Qualifications

• Bachelor\'s degree in Engineering, Life Sciences, or a related technical field
• Minimum 3 years of hands-on validation experience in a regulated environment (medical device preferred)
• Proficiency in developing and executing IQ/OQ/PQ protocols and reports
• Strong knowledge of GMP, QSR, ISO 13485, and related regulatory standards
• Familiarity with validation tools and systems such as TrackWise or Minitab (preferred)
• Excellent technical writing, organizational, and communication skills