Validation Engineer (Sterilization & Process Characterization)

ProQuality Network; Northern (KY); Híbrido; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

ProQuality Network seeks a Validation Engineer to support sterilization load validation and process characterization in a regulated manufacturing environment. You will design, execute, and report validation activities for autoclave cycles and related processes, ensuring GMP compliance.

The role requires 4+ years in validation engineering, experience with sterilization/cleaning validation, and cross-functional collaboration.

Formación

• Bachelor’s degree in Engineering, Science, or related field; advanced degree preferred.
• 4+ years of validation engineering in regulated manufacturing (pharma/biotech/medical devices).
• Experience with GMP and validation lifecycle documentation.
• Experience with sterilization and cleaning validation; equipment qualification.
• Ability to troubleshoot complex validation issues and interpret data.
• Experience in Puerto Rico’s pharmaceutical/biotech industry desirable.

Responsabilidades

• Develop, execute, and report validation protocols for sterilization loads and autoclaves.
• Design and characterize autoclave/cleaning cycles for process tools and components.
• Coordinate testing with manufacturing, quality, and labs.
• Access and manage data using systems such as LIMS and PI-Historian for documentation and trending.
• Prepare and submit validation reports and supporting documentation packages.
• Support SOP and batch record updates for validated processes.
• Collaborate across cross-functional teams to align with schedules and regulatory expectations.
• Provide training and technical guidance to personnel as needed.
• Work evenings/weekends/holidays as required to support validation execution.

Conocimientos

Sterilization validation

Cleaning validation

Equipment qualification

GMP compliance

Cross-functional collaboration

Troubleshooting

Educación

Bachelor’s degree in Engineering/Science

Herramientas

LIMS

PI-Historian

Descripción del empleo

Validation Engineer (Sterilization & Process Characterization)

Title: Validation Engineer (Sterilization & Process Characterization)

Eligibility: Open to residents of Puerto Rico who are U.S. Citizens

Employment Type: Contract position through ProQuality Network

Summary

Our client is seeking a Validation Engineer to support process characterization and validation activities within a sterile drug product manufacturing environment. The selected professional will contribute to the design, execution, and reporting of sterilization load validation studies, ensuring compliance with internal procedures and regulatory standards. This opportunity involves hands-on work in validation engineering, autoclave cycle characterization, and process improvement initiatives supporting ongoing manufacturing operations.

Key Responsibilities

• Develop, execute, and report characterization and validation protocols for sterilization loads and autoclaves.
• Design and characterize autoclave and cleaning cycles for process tools and components.
• Coordinate testing and scheduling activities with manufacturing, quality, and laboratory teams.
• Access and manage data using systems such as LIMS and PI-Historian for documentation and trending.
• Prepare and submit comprehensive validation reports and supporting documentation packages.
• Support updates to standard operating procedures (SOPs) and batch records as required by validated processes.
• Collaborate across cross-functional teams to ensure alignment with project schedules, quality standards, and regulatory expectations.
• Provide training and technical guidance to manufacturing, quality, and engineering personnel as needed.
• Work flexibly, including potential evening, weekend, or holiday shifts , to support validation execution phases.

Qualifications & Experience

• Bachelor’s degree in Engineering, Science, or related field (advanced degree preferred).
• Minimum of 4+ years of relevant experience in validation engineering within a regulated manufacturing environment (pharma, biotech, or medical devices).
• Demonstrated expertise in sterilization validation, cleaning validation, and equipment qualification.
• Proven ability to troubleshoot complex validation issues and apply advanced engineering principles.
• Strong understanding of GMP regulations and validation lifecycle documentation.
• Excellent communication, organizational, and analytical skills.
• Prior experience supporting validation projects in Puerto Rico’s pharmaceutical or biotech industry is highly desirable.