Validation Engineer: Equipment & Process Qualification Lead

SWM International; Dallas (TX); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

Mativ is a global leader in specialty materials, seeking a Validation Engineer to manage equipment, processes and documentation to ensure compliant, high‑quality manufacturing. The role involves developing and executing validation plans, protocols (IQ/OQ/PQ), and handling change controls and CAPAs in a cGMP environment.

The ideal candidate will apply statistics, risk assessment, and cross‑functional collaboration to maintain validated state while working under FDA and ISO guidelines.

Formación

• BS in Engineering (Chemical preferred) or related field.
• 3+ years of validation work experience in pharma/medical device.
• Experience with validation of cleaning, software, automated systems, packaging and lab equipment.
• Proficiency in FDA/cGMP/ISO guidelines and risk management.
• Strong written and oral communication; ability to author SOPs.

Responsabilidades

• Performs validation studies on manufacturing equipment and processes to ensure compliance and quality.
• Generates, reviews, and executes master validation plans and IQ/OQ/PQ protocols.
• Manages change controls, CAPAs, deviations, and documentation throughout validation lifecycle.
• Applies SPC concepts to monitor processes after transfer to production.
• Investigates deviations and performs root-cause analysis.

Conocimientos

BS in Engineering

3+ years validation experience

FDA cGMP knowledge

SOP writing

Statistical analysis

FMEA

Project independence

Cross-functional teamwork

Documentation skills

Educación

Bachelor's degree in Engineering (Chemical preferred)

Herramientas

Validation protocols (IQ/OQ/PQ)

Validation software

Descripción del empleo

Mativ is a global leader in specialty materials, seeking a Validation Engineer to manage equipment, processes and documentation to ensure compliant, high‑quality manufacturing. The role involves developing and executing validation plans, protocols (IQ/OQ/PQ), and handling change controls and CAPAs in a cGMP environment.

The ideal candidate will apply statistics, risk assessment, and cross‑functional collaboration to maintain validated state while working under FDA and ISO guidelines.