Validation Quality Engineer

Inteldot • Dorado, PR

2d • Onsite

About The Position

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. Employment type: Full time and onsite role. Role Summary: Support multiple new line development projects by executing Tool Qualifications (TQFs), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), and In-Process Monitoring (IPM) by leveraging automated tools and site-level expertise.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in Validation (OQ/PQ/TMV/IPM)
• 3+ years of experience in Quality Engineering
• Strong understanding of Validation lifecycle and documentation
• Strong understanding of Regulated environments (FDA, ISO, GMP)
• Experience with Data analysis tools (Excel – advanced)
• Experience with Document management systems (e.g., Windchill preferred)

Nice To Haves

• Strong analytical and problem-solving skills
• High attention to detail and data integrity
• Ability to apply technical judgment in ambiguous scenarios
• Effective communication and escalation skills
• Ability to work independently in a fast-paced, high-priority environment

Responsibilities

• Validate multiple processes as needed/applicable following site practices and documentation
• Cross-check validation records against: - MVPs (Master Validation Plans) - PRAs (Product Risk Assessments) - Supporting validation documentation
• Identify and quantify products requiring remediation across OQ, PQ, TMV, and IPM
• Highlight high-risk, complex, or ambiguous scenarios requiring deeper analysis
• Proactively identify: - Data gaps - Inconsistencies - Tool limitations
• Escalate risks, uncertainties, or blockers to the core team in a timely manner
• Provide clear documentation of findings and recommended actions

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level