Sr. Cleaning Validation Engineer

2 weeks ago

Bedford, United States a Medical Devices company in MA Full time

Senior Validation Engineer


RESPONSIBILITIES

  • Leading start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device, and drug product manufacturing processes.
  • Leading the delivery of validation within complex, capital projects overseeing engineering, quality, and compliance aspects of validation.
  • Authoring, executing, and summarizing qualification and validation protocols.
  • Conducting Risk / Impact assessments and establishing system boundaries.
  • Ensuring protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
  • Coordinating the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or validation.
  • Initiating and/or providing validation input on quality systems such as CAPAs and change controls.
  • Responsible for other duties and projects as assigned.


RESPONSIBILITIES

  • Minimum 8+ years of cleaning validation experience in pharmaceutical, medical device or FDA regulated environments.
  • Strong understanding of cGMP and regulations related to facility, utility, equipment, and process validations.
  • Ability to initiate, manage and close quality systems such as change control, CAPA and deviation management.
  • Detailed experience performing root cause analysis investigations for deviations and non-conformances having technical scope.
  • Excellent written and verbal communications skills.
  • Solid understanding of quality risk management principles and statistical concepts as applicable to area of responsibility.
  • Subject matter expert on regulations and best practices pertaining to validation.
  • Practical application and knowledge of ISO 13485, GHTF Process Validation Guidance and other applicable standards used in the medical device manufacturing.


EDUCATION

  • B.S. degree in Engineering or related discipline

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