Validation Engineer
Norwich Pharmaceuticals - Norwich, NY

This job posting is no longer available on Norwich Pharma Services. Find similar jobs: Validation Engineer jobs - Norwich Pharmaceuticals jobs

The Validation Engineer conducts validation assessments of Computer, equipment, facilities and process systems. Compile and analyze validation data, prepare protocols, reports and make recommendations for changes and/or improvements and maintains appropriate validation documentation and files.

Organization Structure:

The Validation Engineer reports directly to the Manager Validation.

Responsibilities:

  • Manage Computer System Validation
  • Electronic Records & Electronic Signature Assessments
  • Risk Assessment
  • Supplier Assessment
  • Write/Review/Approve validation deliverables
  • Manage Equipment and Instrumentation Qualification
  • Write/Review/Approve qualification deliverables
  • Commissioning
  • Manage Facility and Utility Qualification
  • Write/Review/Approve qualification deliverables
  • Commissioning
  • Manage Process Validation
  • Write/Review/Approve process validation deliverables
  • Manage Cleaning Validation deliverables review and approval (as appropriate)
  • Write/Review/Approve cleaning verification/validation deliverables
  • General Duties – Facilitate and/or support validation training, Project management activities as required, manage Annual Product Review (APR) including validation and change control, manage periodic review of validated systems, equipment, cleaning and processes and support change management.

  • Qualifications:

    Bachelor degree or comparable work experience/skill sets. Previous work experience will include exposure to a broad range of Pharmaceutical Validation activities such as document control, information technology, production record review, GMP Compliance, Computerize System Supplier Assessment, validation, change control, etc.

    GMP Decision Making Authority:

    Has authority to assign validation strategy/assessment for compliance/ GMP capability. Additional approval authority for procedures, protocols and standards will be designated by the Department Manager as needed.

    About this company
    6 reviews
    With a focus on improving patient outcomes, Norwich is a reliable partner for all stages of the product lifecycle. Norwich is a...