QC Lab Equipment Qualification Support

Development and execution of Laboratory Equipment Validation.  Development of Validation Plan, Risk Assessment, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs. Execution of related validation protocols.  Development of documentation packages for all activities, including: Original format documents, approved document and applicable drawings.

Qualifications

• Bachelor Degree in Chemistry or related discipline
• Experience developing Validation Plans, Risk Assessments, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs.
• Validation Experience in Computer Systems
• 21 CFR Part 11 practical knowledge
• Strong knowledge in GMPs regulations
• Technical Writing Experience
• Validation expertise in:
  Sterilization
  Kaye Validator & Data loggers
  Process Validation
  Equipment Qualification
  Re-qualification
  Computer System Validation
   

Additional Information

Positions available for Puerto Rico.

Only candidates that meet the minimum requirements will be considered.

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.