Computer System Validation Engineer
We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you are looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.
Agenus, a biopharmaceutical company focused on immunology-based approaches to the discovery and development of novel therapies for cancer and infectious diseases, is seeking a highly motivated person to join the Information Technology group and work as part of an integrated team to advance technology in our organization. This role perform computer system validation (CSV) for systems that support the production of biologics. CSV helps to ensure that both new and existing computer systems consistently fulfill their intended purpose and produce accurate and reliable results that enable regulatory compliance, fulfillment of user requirements, and the ability to discern invalid and/or altered records.
- Support the development and execution of CSV deliverables according to regulatory authorities for GxP computer systems to support commercial and development activities.
- Support the assessment of pre-existing GxP computer systems for compliance gaps and recommend solutions.
- Support the coordinate and/or performance of all CSV.
- Provide guidance for CSV activities performed by contract service providers
- Assess change controls for impact to validated computer systems
- Participate in cross-functional project teams to ensure business needs are met and implemented in compliance with associated predicate rules and governing regulations.
- Pro-actively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices.
- Build and maintain trusting, collaborative relationships and partnerships with internal stakeholders, which help accomplish key business objectives.
Qualifications and Education Requirements
- Bachelor's degree in Business Administration (concentration in Information Systems or related IT), Computer Science, Information Systems, or related
- 5 years of progressive, post-baccalaureate experience in Computer Systems Validations.
- Previous experience must include working with GxP technologies, configuring softwares, the troubleshooting process and associated changes and CAPA processes, Windows security controls, Data migration, database-oriented applications, and Enterprise systems including Training/Laboratory (LIMS)/Document management (EDMS) systems.