Objective
We are looking for a Validation Quality Engineer to 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.
Details
• Execute and/or approve: OQ (Operational Qualification)
PQ (Performance Qualification)
TMV (Test Method Validation)
IPM (In-Process Monitoring)
• Apply technical judgment to:
Confirm applicability of validation documentation and risk documentation
Identify discrepancies such as missing, conflicting, or outdated records
• Ensure alignment with:
Current procedures
Global validation standards
Remediation expectations and timelines
Key Responsibilities
1. Validation Engineer
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
2. Identification & Escalation
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
Qualifications & Experience
Bachelor's degree in Engineering, Life Sciences, or related field
3+ years of experience in:
• Validation (OQ/PQ/TMV/IPM)
• Quality Engineering
Strong understanding of:
• Validation lifecycle and documentation
• Regulated environments (FDA, ISO, GMP)
Experience with:
• Data analysis tools (Excel - advanced)
• Document management systems (e.g., Windchill preferred)
Key Skills
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
