Validation Engineers

Careers

Caguas, PR, United States2w ago

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Key details

Location
Caguas, PR, United States
Work style
Onsite
Level
Mid level
Job type
Contract
Function
Hardware, mechanical & civil engineering
Focus area
other
Posted
2w ago

Skills

fmeagmphvac

About the role

We are seeking Validation Engineer professionals to support validation activities for sterile manufacturing, plant operations, facilities, equipment, systems, room requalification, and project-based validation initiatives. Assignment may include one or more active site projects, depending on project need. The role includes authoring and executing protocols, supporting field execution, documenting results, resolving discrepancies, and owning validation deliverables through closeout.

Project Assignment Areas
  • Grade D Manufacturing Environment project, including Central Dust Extraction, Grade D area/suite qualification, and equipment relocation validations.
  • Bulk IPA Storage systems validation.
  • Fillers Relocation room requalification.
  • Pledget Dust Remediation dust-extraction equipment validation.
  • Plant operations and quality project validation scope.
  • Facilities-related validations for designated engineers, including HVAC, utilities, and cleanroom.
Key Responsibilities
  • Author and execute commissioning and qualification protocols and reports, including IQ/OQ/PQ.
  • Own validation deliverables through execution, discrepancy resolution, and closeout.
  • Execute field activities and document results in accordance with applicable validation requirements.
  • Support equipment, systems, facilities, utilities, cleanroom, room requalification, and project validation activities as assigned.
  • Perform risk-based assessments and support FMEA activities where applicable.
  • Coordinate validation deliverables with QA, Engineering, and Manufacturing.
  • Support multiple concurrent projects, depending on assignment.


Requirements

Required Qualifications
  • Bachelor’s degree in Engineering or a related technical field.
  • Minimum 5 years of validation experience in a regulated environment.
  • Hands-on IQ/OQ/PQ authoring and execution experience.
  • Experience supporting equipment, systems, facilities, utilities, cleanroom, and/or regulated manufacturing validation.
  • Working knowledge of cGMP and 21 CFR 210/211.
  • Strong technical-writing skills.
  • Ability to work on-site in El Paso, Texas.
  • Bilingual English/Spanish preferred.
Preferred Qualifications
  • Sterile / combination drug-device manufacturing background.
  • Experience with Kneat.
  • ISO 14971 / FMEA experience.
  • Cleanroom / ISO 14644 experience.
  • Validation leadership experience, where applicable.


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