Quality Validation Engineer

Validation & Engineering Group, Inc.; Dorado (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a dedicated Validation Engineer to support multiple development projects by executing OQ, PQ, TMV, and IPM activities.

You will validate processes, assess documentation, and ensure alignment with current procedures and global standards. Candidates should possess a Bachelor's degree in Engineering or Life Sciences and 3+ years in validation/quality engineering, with strong Excel skills and experience using Windchill.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3+ years of experience in validation (OQ/PQ/TMV/IPM) and quality engineering.
• Strong understanding of validation lifecycle and regulated environments (FDA, ISO, GMP).
• Experience with data analysis tools (Excel – advanced) and document management systems (e.g., Windchill).

Responsibilities

• Validate multiple processes as needed following site practices and documentation.
• Cross-check validation records against MVPs, PRAs, and supporting validation docs.
• Identify and quantify products requiring remediation across OQ, PQ, TMV, and IPM.
• Highlight high-risk, complex, or ambiguous scenarios requiring deeper analysis.
• Issue identification and escalation; escalate risks, uncertainties, or blockers to the core team.
• Provide clear documentation of findings and recommended actions.

Skills

Analytical skills

Attention to detail

Technical judgment

Communication skills

Independent work

Education

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

Tools

Excel (Advanced)

Windchill

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Objective

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.

Scope of Work

• 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

• 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
• Issue 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 documentationRegulated 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

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.