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Senior Software Validation Engineer
Senior Software Validation EngineerStaftonic LLC • Sunnyvale, CA, United States
Senior Software Validation Engineer

Senior Software Validation Engineer

Staftonic LLC • Sunnyvale, CA, United States
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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 :

  • Bachelor’s in engineering, Computer Science, Information Technology, or Life
  • Sciences, etc.
  • Minimum of 6 years of Engineering work experience with a BS in the medical
  • device or similarly regulated industry
  • Preferred 3 years’ experience in a software validation function in a regulated
  • environment
  • Deep understanding of GAMP 5, 21 CFR Part 11, Annex 11, and ISO 13485.
  • Experience implementing and validating systems in a cloud / SaaS environment.
  • Experienced in Microsoft Office, Google Suite, Jama, and ePLM / eQMS systems.
  • Must be a self-starter, team builder, and excellent in verbal and written
  • communication.
  • Preferred Certifications : GAMP Practitioner, PMP, ASQ-CQA, etc.
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    Validation Engineer • Sunnyvale, CA, United States

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