Senior Computer Systems Validation Specialist

job summary:
Position Overview We are seeking an experienced Senior Computer Systems Validation (CSV) Specialist to provide comprehensive business and systems support for software applications and laboratory instrumentation. In this role, you will lead the initiation and completion of Performance Qualification (PQ) validation, facilitate system upgrades, and guide the implementation of new technologies. As a key member of the project team, you will ensure that all systems perform reliably, accurately, and in full compliance with regulatory standards and internal Standard Operating Procedures (SOPs).

location: Telecommute
job type: Contract
salary: $45 - 50 per hour
work hours: 8am to 5pm
education: Bachelors

responsibilities:
Provide end-to-end validation support for new software releases and application modifications throughout the Software Development Life Cycle (SDLC). This includes preparing validation plans, test cases, and summary reports.

· Execute test scripts to produce empirical evidence of system reliability. Create and manage test data environments to accurately challenge functional requirements and ensure business expectations are met.

· Review and approve change controls associated with validated systems. Ensure all activities adhere to Good Clinical Practices (GCP) and SOPs. Prepare for and represent the department during internal, client, and vendor audits.

· Participate in multidisciplinary project teams, providing direction on future system enhancements. Proactively communicate timelines, resource constraints, and budget feedback to management.

· Cross-train and mentor junior team members and internal testers. Assign and review work for accuracy, providing technical guidance on complex validation issues and directing the efforts of contractors and temporary staff.

· Participate in corporate and departmental process initiatives to streamline validation workflows and enhance system performance.

qualifications:
- Bachelor's degree or equivalent relevant formal academic/vocational qualification.

- Minimum of 5+ years of experience in computer systems validation, software testing, or laboratory informatics.

- Thorough understanding of the Software Development Life Cycle and clinical trials operational processes.

- Solid knowledge of computer systems validation (CSV) regulations, GCPs, and system testing processes.

- Mastery of Microsoft Office Suite (Word, Excel, PowerPoint, and Project) and a proven ability to learn specialized laboratory or clinical software with minimal instruction.

- Experience representing systems in client/audit forums and participating in vendor audits.

- Demonstrated ability to identify technical problems, troubleshoot software defects, assess the cause of test failures, and explain error production in a professional environment.

- Proven ability to manage multiple assignments with conflicting deadlines, negotiate schedule changes, and adapt to changing project priorities.

- Strong oral and written communication skills with a client-focused approach and the ability to teach/mentor others effectively.

- A high degree of accuracy in data handling and the execution of test scripts to ensure system integrity.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.