Computer Systems Validation Engineer III
5 days ago
Job Summary:
The Computer Systems Validation Engineer III will be responsible for ensuring the digital systems at Resilience Corp. are validated and maintained in a validated state in accordance with regulations and company standards. This includes developing and implementing a risk-based validation methodology, collaborating with global and site stakeholders, and providing guidance on CSV processes and electronic validation lifecycle management tools.
Key Responsibilities:
- Develop and implement a risk-based validation methodology to ensure digital systems are validated and maintained in a validated state.
- Collaborate with global and site stakeholders to develop a highly effective validation program.
- Provide guidance on CSV processes and electronic validation lifecycle management tools.
- Support internal and external audits of digital systems to verify that systems are validated and maintained in a validated state.
- Manage various aspects of digital systems to ensure the operational phase is in a state of compliance.
Requirements:
- Extensive experience in federally regulated industries or CSV teams in Pharmaceutical / Biotech industry with comprehensive expertise and working knowledge of GxP, 21 CFR Parts 11, and Annex 11 compliance requirements.
- Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles, Agile development, and deployment approaches.
- Fluid collaboration skills across business, Digital, and external vendors/suppliers.
- Enhanced technical writing skills with attention to detail along with excellent communication skills.
Preferred Qualifications:
- B.S. degree in Computer Science, Engineering, or related field with 7+ years of relevant progressive experience, within the pharmaceutical/biotech industry.
- Knowledge and understanding of risk assessment tools.
- Fluency in supporting the digitization of Computer Software Assurance processes by bringing the QA know-how to peers in Digital.
- Builder mentality that seeks to produce innovation, agility, and velocity to support business-as-usual operations and new project implementation.
About Resilience Corp.
Resilience Corp. is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
Why Join Resilience Corp.
At Resilience Corp., we offer a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.
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