Senior Software Validation EngineerStaftonic LLC • San Mateo, CA, United States
Senior Software Validation Engineer
Staftonic LLC • San Mateo, CA, United States
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job_description.job_card.job_descriptionBachelor’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.
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 :
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Validation Engineer • San Mateo, CA, United States