Engineer, Computer System Validation

Location: Emeryville, CA
Department: Information Technology

Position Summary

The Engineer, Computer System Validation is responsible for maintaining GxP applications in a validated state and hands on administrative support for GxP applications and related computer systems including processing access requests, reviewing operational SOPs, assisting in evaluating application upgrades to assure that upgrades and enhancements are completed on time while meeting all CSV compliance requirements. The position will also work on implementing data migrations, executing, and reviewing audit trails as needed to assure data integrity in all GxP systems.

Essential Duties and responsibilities

  • Assist with CSV validation issues and discrepancies; support investigation of CSV defects and quality records (deviations and CAPAs).
  • Administer GxP and R&D systems,
  • Implement and validate GxP Systems, eTMF, EDMS, electronic signatures, and related systems.
  • Perform audit trail reviews.
  • Provide support to external and internal audits related to GxP application operational activities.
  • Assist in maintaining externally hosted GxP applications including SaaS applications in a validated state.
  • Work in conjunction with contract resources and Managed Service Providers on projects and ongoing operational needs.
  • Contribute to projects related to application improvements and system reliability.
  • Partner with the Sr. CSV Validation Engineer to maintain system validation, and Business Owners to assist with application enhancements, impact assessments and periodic reviews.
  • Author Change Control requests, manage the process and coordinate completion of changes.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Other responsibilities are performed as assigned or needed.

Core Competencies, Knowledge and Skill Requirements

  • Veeva Vault eTMF and BOX system administration
  • Veeva CTMS (EDC), Veeva Safety, Metadata Rave a plus
  • Demonstrated knowledge of CSV and CSA best practices, Electronic Records/Electronic Signatures, 21 CFR Part 11, 210, 211, 820.and Annex 11 and GAMP 5 principles in the biotechnology or pharmaceutical industry.
  • Knowledge and expertise with Software as a Service (SaaS) systems, automated process equipment and clinical data management software in the biotechnology or pharmaceutical industry.
  • Proven ability to think critically, demonstrated troubleshooting and problem-solving skills and decision making.
  • Ability to function efficiently with minimal supervision in a rapidly changing environment.
  • Must have excellent project management skills.
  • Solid skills in Office 365 applications (Outlook, Word, Excel, PowerPoint, SharePoint)

Communication & Interpersonal Skills

  • Excellent verbal and written communication skills
  • Ability to effectively collaborate in a dynamic environment
  • Highly motivated and flexible; thrives in a fast-paced and changing environment; excellent interpersonal and team orientation skills to work effectively with managed service providers as well as IT R&D team members

REQUIREMENTS

Education

  • BS or equivalent experience in life science and/or information systems technologies.

Experience

  • 3+ years of administering and providing end user support and CSV experience in the pharmaceutical, biotechnology and/or medical device manufacturing.
  • Experienced in gap analysis, remediation plans and corrective and preventive action (CAPA), in reviewing, modifying, and writing standard operating procedures (SOPs).
  • Must have hands on experience in maintaining SaaS applications to meet business requirements.
  • Experience in Veeva Vault eTMF and BOX preferred, Veeva CTMS (EDC), RIM and Safety a plus.
  • Experience in authoring CSV documentation and related SOPs

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT

  • Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
  • Ability to work on a computer for extended periods of time.
  • Regularly required to sit for long periods of time, and occasionally stand and walk.
  • Regularly required to use hands to operate computer and other office equipment.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, climb, and lift to 20 pounds.