Computer Software Assurance Specialist

3 weeks ago


Toledo, Toledo, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Computer Software Assurance (CSA) Analyst to join our team at Resilience. As a CSA Analyst, you will be responsible for ensuring the validation and compliance of our digital systems and applications.

Key Responsibilities
  • Develop and implement a risk-based validation methodology to ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • 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 to verify compliance with regulations and Resilience standards.
  • Manage various aspects of digital systems to ensure operational compliance.
Requirements
  • Extensive experience in federally regulated industries or CSV teams in Pharmaceutical / Biotech industry.
  • Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles.
  • 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.
  • Knowledge and understanding of risk assessment tools.
  • Fluency in supporting the digitization of Computer Software Assurance processes.
  • Builder mentality that seeks to produce innovation, agility, and velocity to support business-as-usual operations and new project implementation.
About Resilience

Resilience 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.

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, family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement, and support for caregiving needs.

Our target base pay hiring range for this position is $80,000.00 to $117,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills, and knowledge.



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