Computer Systems Validation Engineer III

3 weeks ago

West Chester, Ohio, United States Resilience Corp. Full time
Job Title: Computer Systems Validation Engineer III

Resilience Corp. is a 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.

The Computer Systems Validation Engineer III will be the key person in Resilience Digital Applications, supporting our site located in West Chester, Ohio. This role will collaborate with global and site stakeholders such as the system owner, process owner, quality, engineering, and manufacturing to develop a highly effective validation program by adopting global standards and processes.

The incumbent shall always consider critical thinking and a risk-based approach during every aspect of the system lifecycle. Provides Computer Systems Validation support for Digital Systems and Technology Solutions.

Key Responsibilities:

  • Develop and apply a risk-based methodology to assurance/validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Use knowledge and expertise in blending traditional GAMP5/CSV/CSA principles and practices with an agile QRM approach in the right proportions to fit large, complex, mission-critical, site or enterprise-level applications.
  • Oversee activities of Digital GxP compliance and work closely with the Manufacturing Applications team, Digital Security, Digital Operations, Project Management teams, and third-party vendor teams to ensure coverage and consistency in testing.
  • Support the development of policy, process, and procedures of computer systems validation (CSV) programs.
  • Create, review, and update computer system lifecycle documentation (SDLC) deliverables (e.g. validation plans, business process maps, data flow diagrams, user acceptance tests).
  • Ensure computer systems are validated and maintain their validated state to support Operations Schedule Adherence requirements.
  • Partner with Quality to ensure Change Controls, Deviations, and CAPAs are closed on time with rigor and velocity.
  • Design, create, and deliver training to Digital Sites that drives compliance of Data Integrity, Computer Systems Assurance, and traditional CSV.
  • Support internal and external audits of digital systems to verify that systems are validated and maintained in a validated state in accordance with regulations and Resilience standards.
  • Manage various aspects of digital systems to ensure the operational phase is in a state of compliance.
  • Support requalification activities for validated in use manufacturing systems such as automated material handling systems, serialization, historians and ERP systems.
  • Aid in Change Control development and strategy as well as provide CSV impact assessments for the proposed digital change requests.
  • Develop and execute Data Migration Plans as required for digital system migrations.
  • Provide guidance for other site departments on CSV processes and electronic validation lifecycle management tool.

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, in implementing and maintaining GXP computer systems in a validated state.
  • 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.
  • 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.
  • Experience validating and qualifying applications for different business areas such as Supply Chain, Engineering, Manufacturing, Laboratories, Regulatory, Quality Systems, and more.
  • Knowledge/experience in CSA (Computer Software Assurance) and related processes/documentation.
  • Experience with electronic validation lifecycle management tools.

Equal Employment Opportunity:

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws.

Benefits:

Resilience offers employees 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.

Target Base Pay Hiring Range: $80,000.

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