CSV Specialist - USDM Life Sciences
Rockville, MD
About the Job
About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
USDM is seeking a highly skilled and proactive Computer System Validation (CSV) Specialist to join our dynamic team. The ideal candidate will possess extensive experience in generating CSV documentation and be proficient in managing laboratory systems, particularly Empower and Labware. This role is crucial for ensuring our systems adhere to current standards and regulatory requirements.
Primary Responsibilities
- Develop and maintain CSV documentation, including Validation Plans (VP), Validation Project Summary (VPS), User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and Test Matrices (TM).
- Generate robust testing protocols for Installation Qualification (IQ), Site Acceptance Testing (SAT), and User Acceptance Testing (UAT).
- Conduct periodic reviews and audits of existing systems to ensure continuous compliance and efficiency.
- Design and execute migration plans for system upgrades and integrations.
- Maintain and update Standard Operating Procedures (SOPs) and quality management systems (QMS) documentation.
- Provide expertise and support for Veeva systems including document management, quality management, and training modules.
- Work independently with minimal supervision, while also collaborating effectively with cross-functional teams to meet project deadlines and objectives.
Qualifications
- At least 5 years of direct experience in computer system validation within a laboratory setting.
- Strong foundation in Computer System Validation (CSV) with hands-on experience in creating detailed CSV documentation.
- Proficiency in laboratory information management systems, especially Empower and Labware.
- Experience with Veeva systems including Docs, QMS, and training.
- Demonstrated ability to write clear, structured, and comprehensive SOPs and documentation.
- Proven ability to work proactively and independently in a lab-oriented environment.
- Excellent problem-solving skills and the ability to manage multiple tasks simultaneously.
- Strong communication and interpersonal skills.
Education & Certification Requirements
- Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
- Certification or formal training in CSV, Veeva systems, or related areas is a plus.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
- Operate other office productivity machinery, such as a calculator, scanner, or printer.
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.