Senior Manager, Computer Systems Validation

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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• Senior Manager, Computer Systems Validation (CSV) – Cell Therapy

  Location: Summit, NJ
  Department: Equipment Commissioning and Qualification Organization

  Position Summary

  The Senior Manager, Computer Systems Validation (CSV), Equipment Commissioning & Qualification supports design, development, delivery, validation, maintenance, and support of GMP computerized systems at multi-use sites. This individual interacts with internal team members, peer-level customers, and external service providers, supporting multiple projects and ongoing activities to ensure regulatory compliance. The Senior Manager supervises contract and/or full-time staff to facilitate departmental deliverables and directly supports CTDO Summit.

  Key Responsibilities

  Management:

  • Lead a team of up to 9 people.
  • Interview and hire internal/external personnel as needed.
  • Provide direction to team members.
  • Set individual and team contributions.
  • Ensure appropriate training for all team members.
  • Promote safety and adherence to site EHS procedures and guidelines.
  • Ensure full compliance with BMS policies and procedures.
  • Staff team appropriately and ensure technical competence across equipment technologies and groups.

  Commissioning, Qualification, and Validation Activities:

  • Manage and allocate resources for CSV activities on laboratory and manufacturing computerized systems.
  • Provide technical input for validation deviations, technical assessments for change requests, and identify qualification/validation requirements for GMP compliance.
  • Assist in design, analysis, execution, and approval of IQ, OQ, PQ, and UAT protocols and reports.
  • Perform technical reviews of validation deliverables.
  • Develop technical support manuals and address system troubleshooting pre and post system release.
  • Build and manage a team capable of learning and configuring new applications, system architectures, and instrumentation.
  • Identify regulatory gaps and provide technical/procedural mitigations.
  • Address technical and compliance challenges across the System Validation Lifecycle; research, test, and generate solutions.
  • Perform 21 CFR Part 11 and system risk assessments.
  • Define needs, benefits, and technical strategy within the project life-cycle and processes.
  • Ensure CSV resources are knowledgeable of latest industry regulations and initiatives.
  • Lead Continuous Improvement efforts for the program.
  • Promote and provide excellent customer service and support.
  • Provide technical support and guidance on equipment and computer systems qualification and validation issues.
  • Foster a positive team environment within the Equipment Commissioning & Qualification department and with site customers.

  Regulatory:

  • Ensure computerized standalone systems are implemented and maintained in compliance with regulatory requirements.
  • Serve as subject matter expert during internal audits or external regulatory inspections.

  Reporting:

  • Reports to Equipment Commissioning and Qualification Organization.

  Qualifications

  • BS in Computer Engineering, Computer Science, or related discipline preferred.
  • Minimum 10 years’ experience in a GMP environment.
  • Minimum 7 years’ experience in pharmaceutical computer systems validation in a GMP environment.
  • Minimum 5 years’ experience managing personnel and/or projects.
  • Experience interacting with regulatory agents and auditors in compliance audit environments, including direct face-to-face interactions.
  • Thorough