Senior CSV Validation Lead

National Resilience

National Resilience

East Norriton, PA, USA
Posted on Friday, May 24, 2024

A career at Resilience is more than just a job – it’s an opportunity to change the future.

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.

For more information, please visit www.resilience.com

Sr. Computer System Validation (CSV) Lead

A career at Resilience is more than just a job – it’s an opportunity to change the future.

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.

For more information, please visit www.resilience.com

Position Summary:

Reporting to the Sr. Dir. Engineering, FM & Validation, the Sr. Computer System Validation (CSV) Lead will collaborate with global and site stakeholders to develop and maintain a robust CSV/data integrity validation program by adopting both global and site level standards and processes. The candidate shall utilize a risk-based approach throughout every aspect of the system lifecycle. This is a site-based role in East Norriton, PA.

Position Responsibilities:

  • Provides Computer Systems Validation leadership for both digital and AEQ systems. Develops and applies a risk-based methodology to assurance/validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Provides hands on validation support implementation validation actions for assets withing the ISA-95 Level 3, 2 and 1 categories.
  • Lead data integrity gap assessments and develop remediation programs for existing computerized FUE and AEQ assets.
  • Oversee activities of Digital GxP compliance and work closely with the Biomanufacturing Applications team, Digital Security, Digital Operations, Project Management teams, and third-party vendor to ensure data integrity coverage and consistency in testing.
  • Provide compliance updates to management along with health of the CSV processes and communicate risk-based escalation issues, when applicable. Additionally, ensure resolution of timely closure of quality records such as CAPA, Deviations, and Change Controls.
  • Lead contract resources and service providers with projects and ongoing validation needs.
  • Responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, requirements, specifications, configuration specifications and summary reports along with protocol development and test script execution.
  • Supports 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.
  • Identify improvement opportunities by engaging with stakeholders to ensure processes are optimized and systems are compliant with governing Data Integrity requirements and evolving industry guidance like CSA.
  • Direct the validation process development responsibilities to establish and maintain site level SOPs, Work Instructions, Periodic Reassessment(s), Change Controls and related documents.
  • Collaborate with the Quality organization to maintain a state of control and compliance with established Quality Systems.
  • Lead management of risk-based strategies and system impact assessments of regulated Digital systems.
  • Design, co-create, and co-deliver training that drives System Compliance, Computer Systems Assurance, and traditional CSV.
  • Partner with Engineering & Facilities Management to align/ensure appropriate calibration and/or work order acceptance criteria and frequencies. Support review of firmware/software modifications on FUE/AEQ assets and associated upgrade strategies.

Minimum Qualifications:

  • Hands-on experience with Software Quality Assurance (SQA) methodologies, techniques, approaches, and test automation tools.
  • Experience supporting the pharmaceutical/ Biotech industry required. Cell and gene therapy preferred.
  • Demonstrated ability to think strategically about business, product, and technical challenges from an enterprise perspective experience.


Preferred Qualifications:

  • B.S. degree in Computer Science, Engineering, or related field with substantial relevant progressive experience, within the pharmaceutical/biotech industry.
  • 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. Hands-on experience with Software Quality Assurance (SQA) methodologies, techniques, approaches, and test automation tools.
  • Experience with Veeva QMS and/or Blue Mountain CMMS

#LI-RM

Resilience is an Equal Employment Opportunity Employer. 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. Requests for reasonable accommodation can be made at any stage of the recruitment process.

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. Our target base pay hiring range for this position is $130,000.00 - $167,500.00 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. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.