Validation Engineer: Lead IQ/OQ/PQ & Protocols

Mativ; Dallas (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Mativ is seeking a Validation Engineer in Dallas, TX to lead the master validation plan and to develop IQ, OQ, and PQ protocols for equipment, utilities, and computerized systems. The role ensures compliance with cGMP and regulatory expectations while driving continuous improvement across manufacturing processes.

The successful candidate will prepare documentation, manage change controls, perform risk assessments, and collaborate with cross-functional teams to maintain validated state and data

Qualifications

• BS in Engineering (Chemical preferred) or life sciences or related field.
• 3+ years of validation work in pharmaceutical and/or medical device industries.
• Certified Quality Engineer/Validation professional a plus.
• Experience with validation of cleaning, software, automated systems, packaging and laboratory equipment.
• Experience authoring and executing Validation protocols such as IQ/OQ/PQ and installation/operating.
• Strong understanding of FDA regulations, cGMP, ISO 13485, ICH guidelines and risk management.
• Proficiency in validation software and statistical analysis tools is a plus.
• Excellent interpersonal, communication and documentation skills.
• Ability to work independently and in cross-functional teams in a fast-paced environment.

Responsibilities

• Generates, reviews, and executes the master validation plan and protocols (IQ/OQ/PQ).
• Prepare change management documentation and route for approvals.
• Apply SPC concepts to ensure production processes remain in a validated state.
• Prepare reports and documentation to determine if systems meet criteria.
• Evaluate equipment and procedures to certify compliant operations.
• Investigate validation-related incidents and deviations and drive CAPAs.
• Lead data generation and reporting for periodic monitoring and re-qualification.
• Develop testing protocols and SOPs; communicate with vendors as needed.
• Maintain validation lifecycle documentation including deviations and corrective actions.

Skills

Problem solving

Communication

Documentation

Team collaboration

Education

BS in Engineering (Chemical preferred)

Tools

Validation software

Statistical analysis tools

Job description

Mativ is seeking a Validation Engineer in Dallas, TX to lead the master validation plan and to develop IQ, OQ, and PQ protocols for equipment, utilities, and computerized systems. The role ensures compliance with cGMP and regulatory expectations while driving continuous improvement across manufacturing processes.

The successful candidate will prepare documentation, manage change controls, perform risk assessments, and collaborate with cross-functional teams to maintain validated state and data