Engineer, Computer Software Assurance

Location: Bengaluru, India

Duties & Responsibilities

• Lead, develop, and execute comprehensive Computer System Validation (CSV) strategies, plans, and protocols (IQ/OQ/PQ) in compliance with FDA and global regulatory requirements.

• Oversee validation activities for GxP-regulated computerized systems including ERP, QMS, MES, manufacturing equipment software, data integrity systems, and custom applications.

• Ensure systems meet 21 CFR Part 820, 21 CFR Part 11, and ISO 13485 requirements for software validation and electronic records/electronic signatures.

• Partner with cross-functional teams (Quality, IT, Engineering, R&D, Manufacturing) to ensure compliant system lifecycle management aligned with GAMP 5 guidelines.

• Drive validation documentation creation, review, and approval, ensuring traceability and regulatory readiness. 

• Ensure systems used in support of GxP activities are validated and maintained appropriately in compliance with applicable FDA, EU and other international regulations 

• Serve as the SME during internal audits, supplier audits, and FDA/Notified Body inspections regarding CSV and data integrity.

• Assess system changes, conduct impact analyses, and ensure controlled execution of validation activities in accordance with established change control procedures.

• Maintain strong understanding of data integrity controls aligned with ALCOA+ principles and applicable global guidance documents.

• Develop and improve CSV processes, templates, and procedures to enhance compliance, consistency, and operational efficiency. 

• Participate in change control processes to assess impact upgrades and changes on validated systems; Oversee execution of change actions.

• Coordinate and execute periodic reviews of validated systems per defined schedule; support development of remediation plan, if needed.

Minimum & Preferred Qualifications and Experience: 

Minimum Qualifications:

• 5+ years of experience in Computer System Validation within a regulated medical device, pharmaceutical, or biotechnology environment preferred.

• Advanced knowledge of and hands-on experience with: 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, GAMP5 guidelines, FDA guidance on risk-based software validation and computer software assurance.

• Proven leadership in planning, executing, and documenting validation of enterprise and manufacturing systems.

• Strong understanding of data integrity requirements, audit trails, and system security principles.

• Experience developing validation documentation including URS, design specifications, traceability matrix, validation plans, IQ/OQ/PQ, summary reports, and controlled procedures.

• Excellent analytical, technical writing, and communication skills.

Preferred Qualifications:

• Familiarity with: EU MDR, Annex 11 (EU guidelines on computerized systems) and ISO 27001 (Information Security Management).

• Hands-on experience with validation of cloud-based or SaaS systems.

• Prior experience supporting FDA and Notified Body inspections as a CSV subject matter expert.

• Experience developing or enhancing CSV/QMS processes.

   

Education

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related technical field required.

Language Requirements:

• Advanced English proficiency (written and verbal) required to collaborate effectively with global stakeholders, prepare technical documentation, and participate in regulatory audits and inspections.

Location

• This position is located at our Bengaluru, India office.

The Principal Computer System Validation (CSV) Engineer is responsible for ensuring that computerized systems used in GxP processes at Masimo comply with global regulatory requirements. This role provides strategic oversight of CSV activities across the organization, ensuring compliance with FDA, ISO, and global regulations while enabling efficient and robust system implementations. The Principal CSV Engineer serves as the subject matter expert for validation best practices, data integrity, and software lifecycle processes, partnering with cross functional teams to maintain a compliant computerized environment.