IT Validation Engineer

Hayward, CA, United States
Sep 19, 2020
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
We currently seek an experienced Validation Engineer to join our dynamic and collaborative team. This is an opportunity to participate and make a positive difference in a growing, fast-paced clinical stage company. In this role, you will plan, author, implement and maintain computerized system validation for business systems used to support regulated activities (i.e. GxP). The ideal candidate will have enterprise-level, hosted-application validation experience.

The IT Validation Engineer will collaborate with IT, business function, and Quality staff to develop consistent validation strategies, implement and improve standards for IT change management and collaborate with the IT leadership to define resource allocation and validation timelines.

Responsibilities include, but are not limited to:
  • Gather and documents user requirements from business stakeholders to establish intended use of computerized systems.
  • Author validation deliverables in collaborate with project stakeholders to (e.g. IQ, Validation Plan, Test Plan, Test Scripts, etc.)
  • Manage validation activities of cross-functional teams to ensure validation effort is executed to plan and properly documented in the appropriate validation documents.
  • Support resolution and documentation of protocol and test discrepancies.
  • Ensure validated systems remain in compliance with applicable regulations and internal procedures as changes to the systems are made.
  • Maintain computerized system validation documentation.

  • A minimum of 4 years in direct hands-on experience validating GxP Computerized Systems
  • Advanced knowledge of GxP regulations and approaches to System Life Cycles (SLC) and GAMP

Key Competencies:
  • Excellent written and oral communication skills.
  • Strong planning, organizing, and execution skills.
  • Ability to proactively manage workload and meet deadlines.
  • Develop and implement creative solutions to improve processes.

Other Qualifications:
  • Experience validating Quality, Regulatory and/or Clinical systems a plus
  • Experience validating Veeva Vault applications a plus