Title : Engineer, IT Computer System Validation (CSV)
Location: Morris Plains, NJ
Duration: Temp to Perm Opportunity
- Primary responsibility is to support IT CSV program, and assigned projects by adhering to applicable global regulatory requirements (i.e. 21 CFR Part 11, Part 210, Part 211, Annex 11, Data Integrity) and industry standards (GAMP V, ICH).
- This position will provide timely results in CSV deliverables in assigned areas across the business (i.e. cGMP Manufacturing, Quality) through computer system validation activities intended to ensure procedural (SOP) and business process adherence.
- Engages with multiple roles in multiple functional areas to fully understand and interpret business user requirements, and develop CSV deliverables (VP, IOQ, UAT/PQ, TM, Summary Reports).
- Execute on pre-approved protocols, document and resolve deviations. Performs period reviews and deliver on Action Plans within the Change Controls and/or CAPA.
ESSENTIAL FUNCTIONS(PRIMARY RESPONSIBILITIES):
- Deliver on multiple CSV assigned projects in a fast-paced matrixed team environment.
- Perform validation assessment for proposed changes to validated computerized systems and identify the CSV requirements necessary to maintain the systems CSV status after execution of the change.
- Assess proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provide guidance on the risk-based CSV approach for the system, working with key stakeholders to achieve business goals.
- Deliver on all CSV aspects as part of project work, or act as lead engineer for assigned specific CSV projects.
- Perform formal testing of computerized systems including identifying and implementing tools, setup of testing, documentation, approval and delivery.
- Implement CSV projects based on Software as a Service (SaaS), SDLC and/or Agile based methodology.
- Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer operations, and act as an information resource for the team and wider business.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES):
- Working knowledge an d CSV results delivery experience in cGMP supporting Biotechnology or Pharmaceutical Manufacturing Systems, Quality Control Laboratory Computerized Systems.
- Experience in Enterprise based GXP IT Systems (ERP, LIMS, QMS, DMS, LMS).
- Ability to multitask and author validation plans and protocols, execute on CSV tasks such as testing verification, access controls and audit trail reviews.
- Knowledge of risk-based validation approach and application in developing risk assessments and verification protocols.
- Effective people engagement skills, able to adopt appropriate styles to foster strong team working environments, minimize and manage conflict and cultivate a culture of mutual respect.
- Confident communicator, able to network effectively in a diverse business community.
- Proactive, professional approach undertakes tasks and responds to business requests in a positive and constructive manner.
- Knowledge of cloud-based software validation approach and demonstrated experience in developing UAT/PQ test cases based on requirements and SOPs or Work Instructions.
- Hands-on experience in performing risk assessments (ICH based) and expertise to assess software and/or systems determination based on GAMP 5 model for GXP intended use.
- Familiarity with multiple system types such as ERP and Client, QMS (Veeva Vault), DMS (Veeva Vault Quality Docs), Clinical applications validation based on Veeva Vault (eTMF, CTMS), LIMS etc.
- Demonstrated understanding of ISPE GAMP 5, FDA Data Integrity Guidance, 21 CFR Part 11 and CSV review of business and user requirements, high-level solutions and infrastructure components qualification, combined with CSV system experience.
EDUCATION/ EXP ERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL):
- Combination of education or equivalent direct work experience is acceptable.
- Minimum six to eight years of direct hands-on experience implementing computer system validation (CSV) completion of day to day validation activities in a pharmaceutical/biotech environment.
- IT team members, business functional area employees including Manufacturing, Validation, Quality Compliance, Quality Assurance, Quality Control (QC) Labs, Technical Operations, suppliers/vendors.
- May interact with the health authorities (FDA, EMA) during inspections and audits to explain CSV projects.