Comp. Sys Validation Spec

Computer System Validation Specialist will work the Natera Software Engineering team to ensure appropriate software documentation is in place to support changes to Laboratory and Product software systems.  Working with the QA Software Manager this position will provide value-added guidance throughout the software development lifecycle process.

PRIMARY RESPONSIBILITIES

Participate in software risk management activities

Perform risk and/or impact assessments for Lab, Product, and Quality Management software systems

Review software change requests and maintenance updates along with associated test plans, protocols, and reports

Participate and/or lead computer system validation projects

Draft IQ/OQ/PQ software plans, protocols, and reports

Ensure validation state of software systems are maintained

Act as subject matter expert for CSV compliance during internal and external audits

Perform audit trail reviews

Participate and/or lead cross-functional teams to investigate and resolve software nonconformities, deviations, CAPAs, and complaints.

May support quality system audits as subject matter expert in computer system validation.

Responsibilities are assigned based on demonstrate competency.

QUALIFICATIONS

BS Degree or equivalent work experience

3-5 years’ experience within a dedicated CSV or product software validation role

Experienced working in a CLIA Laboratory environment and/or FDA regulated environment

KNOWLEDGE, SKILLS, AND ABILITIES

Preferred experience/knowledge with Microsoft Great Plains, Confluence, JIRA, SuccessFactors, LIMS, EDMS

Extensive knowledge of QA methodologies, test planning, system dependencies, and product integration phases.

CSV III: Extensive knowledge of regulatory requirements for software design and change control (lifecycle management

Knowledge of regulatory requirements for non-product and product software (IEC 62304, 21 CFR Part 11, 21 CFR Part 820.30 and 820.70(i), CLIA, etc.)

Strong knowledge of QA methodologies (such as root cause analysis), test planning, system dependencies, and product integration phases.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk or hear.

The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

Limited travel required