USDM Life Sciences Overview
USDM Life Sciences provides a variety of IT and compliance solutions to help life sciences companies streamline laboratory, clinical and manufacturing operations while staying in compliance with FDA regulations. USDM disrupts convention and delivers compliance with proficiency, simplicity, and efficiency to achieve better results for our customers that are in the business of saving lives. It’s a place where you can make an impact in the world as a champion for life sciences innovation and also get the experience and mentoring to grow your career.
Founded in Santa Barbara, California in 1999 by two UCSB graduates, USDM has grown to a global company with offices throughout the US, Toronto, Canada and Frankfurt, Germany.
We are seeking a highly motivated IT Computer Systems Validation Engineer with strong skills in CSV, IT, and Quality. Working with the Computer System Validation Manager, this individual will
develop and execute the CSV program at "client", and assist in developing the vision, mission, and strategic objectives for this cross-functional function partnering with Quality Assurance Validation, IT, and business system owners across the organization. This position is responsible for assuring that *clients* GxP computerized systems are compliant with EU, and ICH guidelines and U.S. GxP regulations.
- Develop procedures and work instructions for computer system validation (CSV) including procedures for GxP system development life cycle, creation of validation deliverables, CSV project management, and software vendor quality audit questionnaires.
- Act as IT CSV approver for project-related CSV documents on cross-functional teams that include Business Owners, IT CSV project engineers, IT System Administrators and System Owners, and Quality Assurance on projects including clinical data repositories, master data management systems, laboratory systems, and other systems supporting clinical or quality processes.
- Develop templates for CSV deliverables including validation plan, requirements specifications, design specification, test scripts, and summary reports
- Participate in the development of *clients* IT data governance policies & procedures
- Act as business administrator for *clients* automated system life cycle software application, including managing accounts, change/patch management, and any associated maintenance.
- Proactively maintain IT compliance across GxP IT Portfolio, identifying risks and proactive initiatives, when applicable
- Participate in the review of completed software quality audit questionnaires for software development methodology, testing standards, configuration management, patches, and security assessments
- Help develop and deliver training related to computer system validation and CSV testing
- Periodic Review of CSV packages for configuration reconciliation, change review, and validation maintenance
- Support inspections by regulatory agencies along with internal and external audits as appropriate.
- Participate in internal and external audits with responsibilities to prepare validation packages and defend *clients* computer system validation practices and system development life cycle
- Be willing to mentor and provide direction on CSV to members of project implementation teams, as needed.
- 7+ years of Computer System Validation experience in a GMP/GCP environment.
o Experience in GCP environment is a plus
- Strong facilitation skills to develop consensus and clarity, Ability to communicate and work independently with scientific/technical personnel
- Must have strong organizational skills and be able to execute and potentially manage projects to completion.
- Ability to work cross functionally with all levels of the organization.
- Project management or ASQ, Black Belt/Green Belt certification is a plus
- Active participation/knowledge of ISPE (GAMP) and/or ASQ standards a plus
- Strong understanding and working knowledge of FDA 21 CFR Part 11, 210, and 211, ICH Q8/9/10, and EU Annex 11
- Proficient in MS Word, Excel, Power Point and other applications.
- Strong written and verbal communication skills.
- Bachelor’s Degree in a technical discipline (Computer Science, Engineering, Chemistry/Biology).
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.
USDM Life Sciences is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran, disabled, or any other protected status.