Validation Engineers

•  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, cleanroom, and
  BMS.
  

• 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

• 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.
  

• Sterile
  / combination drug-device manufacturing background.
  
• Experience
  with Kneat.
  
• ISO
  14971 / FMEA experience.
  
• Cleanroom
  / ISO 14644 experience.
  
• Validation
  leadership experience, where applicable.