Computer Systems Validation Manager

Location: Northeast Pittsburgh, PA

Job Type: Full Time / Permanent

The Computer Systems Validation Manager manages validation staffing and task execution for the validation of computer system applications, computer system infrastructure, and computer system hardware. The Computer Systems Validation Manager works with management, especially the Computer System Applications, Information Technology, and Quality Assurance departments, to establish the philosophy for validation approaches.

Responsibilities:

  • Manage day-to-day activities of Computer Systems Validation staff
  • Schedule and coordinate Computer Systems Validation activities with other departments
  • Lead budgeting and planning for outsourced Computer Systems Validation activities
  • Provide evaluations and recommendations for implementing and maintaining automated testing
  • Lead personnel development (e.g. interviews, training, terminations, etc.)
  • Ensure change controls and validation tasks are being completed on time and meet the expected quality standards
  • Supervise, perform, review, and document Computer Systems Validation activities (e.g. VPPs, RAs, IQs, OQs, PQs, VSs, etc.) as needed
  • Work with Quality Assurance to ensure alignment in execution of validation activities to achieve an agreed upon state of control for computer systems and infrastructure
  • Promote effective teamwork and resolve conflicts as needed both internally and with outsourced partners
  • Work and interact effectively and professionally with management at all staff levels
  • Must maintain company quality and safety standards
  • Practice and stay current with ISPE GAMP best practices, FDA and EU GxP regulations, and applicable ISO standards
  • Maintain professional and technical knowledge by attending educational workshops; participating in professional societies

Education & Experience:

  • Bachelor’s degree in Engineering, Information Systems, Life Sciences or related technical field; or 10+ years of experience as a manager of computer system validations
  • 2+ years of experience as a functional manager of validation or testing for at least one of application delivery, software development, or IT infrastructure deployment
  • 5+ years of experience in a Biotech/Pharmaceutical/Med product manufacturing industry regulated by the FDA
  • 5+ years of related experience in System Development Life Cycle (SDLC)
  • Ability to demonstrate leadership and critical thinking
  • Ability to demonstrate technical expertise in planning and execution of validations for computer system applications, computer system infrastructure, and computer system hardware in relation to biopharmaceutical processes
  • Ability to demonstrate an understanding of regulations and guidelines governing biological product development in relation to quality requirements for computer system applications, computer system infrastructure, and computer system hardware
  • Ability to demonstrate excellent organizational, interpersonal, and communication skills
  • Ability to demonstrate expertise in the understanding of principles for application integration and regulations for data integrity
  • Ability to demonstrate knowledge of 21 CFR parts 11, 210, 211, 600, 610, and 1271 along with associated best practices (e.g. ISPE GAMP) for CSV qualifications
  • Demonstrable ability to influence stakeholders and work with them to determine acceptable solutions
APPLY NOW