Senior Computer System Validation Engineer

Location: San Francisco Consulting
Department: Azzur San Francisco LLC

Job Description

 Essential Duties and Responsibilities

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project.  The level of knowledge expected will be commensurate with level of incoming experience.

  • Applies theory, technical principles and judgement to address a broad range of project/equipment/process challenges.
  • Act as a senior technical resource and guide to junior members of the team, working with cross-functional teams to determine technical solutions for manufacturing/QC qualification activities
  • Consolidate and manage process knowledge, serving as a single point of contact for information related to QC and Manufacturing equipment qualification activities and requirements
  • Participate in scope definition/control for qualification activities as appropriate, coordinating efforts between client and consultants on site.
  • Responsible for ensuring manufacturing and QC equipment are qualified to required standard. Review and interpret data for accuracy for completed qualification activities to ensure requirements and acceptance criteria are met. Prepare report packages by analyzing and summarizing data to support test and protocol requirements. Manage troubleshooting efforts for protocol discrepancies.
  • Develop project plans with input from key stakeholders
  • Understand and manage deliverables of all project requirements originating from the proposal, specifications, meetings, verbal direction, or other means
  • Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV)
  • Perform (hands on) field execution of commissioning and/or validation documentation
  • Responsible for working with all team members to ensure timely delivery of project requirements (schedule, budgets, and costs). Ensure project team members work within the project schedule and budgets. Provide updates to client and management indicating status of project as required.
  • Actively participate in the mentoring, training of junior engineers and development of internal company policies and procedures
  • Minimum 7-10 years’ CSV and Equipment Qualification experience in the pharmaceutical and/or biotechnology industry is required.
  • Minimum 5 years of experience in development or manufacturing of gene therapy products, or cell culture products.
  • Follow format and SOPs for all activities, including - completing required training and maintaining compliance with all training requirements and records in the ComplianceWire system.
  • Participate in Full SDLC documentation support within an FDA regulated environment with an emphasis on computerized systems including but not limited to:
    • Requirements elicitation and engineering
    • Performing data integrity/data quality assessments
    • Authoring and reviewing user requirements / functional requirements specifications, design specifications, computer validation plans, test protocols, data integrity assessments and part 11/annex 11 assessments.

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