Lightship is your complete solution for decentralized clinical trials. We built our virtual-first clinical trial model from the ground up, allowing patients to participate in clinical trials from the comfort of home.
We are seeking an experienced computerized systems validation engineer to execution the functional, performance, validation and end-to-end testing of Lightship’s applications. You have a passion for quality and are always on the lookout for process and performance improvements. You are excited about and dedicated to delivering high-quality applications in a dynamic and constructive environment. You are invigorated by new challenges, seek out new learning opportunities, lead from the front, challenge the status quo and build other team members through technical and professional mentorship.
This position may be located at our El Segundo HQ or can be remote with occasional travel (<10%) to the Los Angeles area.
You will be responsible for:
- Representing Computerized System Validation (CSV) process internally and to external partners, potential partners, or regulatory agencies
- Author validation documents including validation plans, protocols, reports
- Author validation test scripts including Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ)
- Support and oversee validation test execution
- Support development of computerized system user requirements and technical specifications
- Author validation discrepancies
- Assist in risk assessments to determine testing strategies
- Participate in change management process as validation lead
- Participate in computerized system vendor assessments
- Perform 21 CFR Part 11 and Annex 11 Assessments
- Ensure computerized systems conform to regulatory requirements (GCP)
- Assess the impact of changes to the validated state of Good Clinical Practices
- (GCP) computerized systems during the operation and maintenance phase
- Evaluate computerized system incidents and deviations for GCP impact
We are excited to speak with someone who has:
- Experience with system integration testing
- Experience with data warehousing and master data management systems
- Experience testing Software-as-a-Service cloud-based applications
- Experience testing Salesforce Platform is a plus
- Experience developing manual scripts to facilitate seamless automation is a plus
- Experience testing applications used to support Clinical trials (e.g., CTMS, IxRS/IRT, eConsent, Patient EDC)
- Experience with planning and executing computer systems validation activities
- Knowledge of and full understanding of system development lifecycle (SDLC) processes
- Knowledge of quality system principles, practices, and standards for the life science industry
- Strong technical writing and verbal communication skills
- Able to evaluate situations, apply critical thinking skills, and propose potential solutions
- Knowledge of 21 CFR Part 11 Electronic Records, Electronic Signatures, Annex 11
- Understanding of industry standards and best practices for computer system validation, such as GAMP 5 and ASTM E2500
- Experience with collaborating across multiple functional/technical teams to deliver a project
Education and experience
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related discipline, or requisite combination of education, training and experience
- 5 or more years experience in life sciences, regulated industry
We would like to offer you:
- An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core
- The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade direct-to-patient clinical research solutions at scale
- An unmatched opportunity to grow as part of an early stage startup with industry veterans, high-caliber investors, and a massive market opportunity
- Competitive compensation
Generous benefits package, including:
- Top notch healthcare (medical, dental, and vision) for you and your family, effective on day one of employment.
- Unlimited Paid Time Off (PTO), plus paid holidays and bereavement to help support work life balance.
- A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.
- Generous paid parental leave
- Short & long-term disability
- Life insurance and More!
Our commitment to diversity & inclusion:
Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law. EEO is the Law
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