Senior Software Validation Engineer (Fremont)

Title : Senior Software Validation Engineer

Location : San Francisco Bay Area

Long Term Project

Key Responsibilities :

• Apply and promote best-practice use of internal Quality Management System to
• ensure regulatory compliance.
• Lead validation efforts for GxP-regulated computerized systems used acrossthe
• organization including quality, manufacturing, clinical, business systems, etc.
• Develop and improve non-product software validation procedures, templates,
• and maintain the software master validation plan.
• Write validation plans, protocols, reports for non-product computer software
• validation.
• Review and approve validation plans, protocols, executed validation protocols
• and summary reports.
• Collaborate with software owners to write intended uses, user requirements, risk
• analysis, and system requirements.
• Evaluate software changes to determine if re-validation is required.
• Manage validation timelines and deliverables to drive completion of software
• validation activities.
• Responsible for other duties as assigned which may include, but is not limited to
• supporting processes within training, document control, audits, and CAPA.
• Support and improve change control processes related to validated systems.
• Ensure validation aligns with internal procedures and external regulatory
• expectations, including GAMP 5 and 21 CFR Part 11.
• Collaborate with IT, QA, Engineering, Manufacturing, Clinical, and external
• vendors to ensure validation activities are executed effectively, efficiently and
• meet regulatory requirements.
• Mentor junior staff and cross-functional team members on computer software
• validation best practices and data integrity principles.

Qualifications and Experience :