Manager, Validation Computer Systems

Company: Renaissance LLC
Location: Lakewood
Posted on: June 25, 2022

Job Description:

Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.OverviewThis position is responsible for supporting the design, installation, implementation and validation of electronic systems to meet all applicable industry standards and regulatory requirements. The successful candidate will act as an advisor to the Director of MS&T in all areas of system compliance and validation and must have the ability to raise issues that they see as risk to the company. This position frequently interacts with customers and other groups at the Site and coordinates the Computer System Validation tasks.Responsibilities--- Guides the work efforts of consultants and other team members, and mentors them in all areas of computer system compliance and validation.--- Responsible for providing input for maintaining the IT Master Inventory of Electronic Systems.--- Provides leadership for GXP computerized systems and applies risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.--- Manage continuous improvement efforts for the CSV program, including guidance for impact as new or revised industry regulations emerge.--- Oversee the overall readiness of the CSV and Data Integrity programs to ensure programs are compliant and ready for regulatory inspections.--- Review and approve software validation strategy in support of custom software systems, COTS configuration, workflow, and/or analytics to assure compliance, overall accuracy, efficiency, and effectiveness of the electronic computerized system.--- Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party IT service suppliers and applications.--- Effectively identify and resolve complex system for compliance issues and appropriately communicates gating items to management and stakeholders.--- Review/assess proposed validated system changes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.--- Participate and support the external audit program for vendors related to GXP computerized systems.--- Prepare gap assessments, user requirements, functional and configuration specifications, traceability matrix, test scripts, validation plans, IQ, OQ, PQ and summary reports. Other validation documentation as needed.--- Coordination of testing activities within the team, report progress of testing and significance of unfavorable results.--- Create, support and provide input into system administration and standard operating procedures (SOPs) to ensure adequate controls for maintaining the validated state. --- Initiate and implement change control activities in accordance with current procedures. --- Participate in internal, client and regulatory agency audits as Subject Matter Expert. QualificationsBachelor's degree in Computer Science, Information Systems, Engineering, or similar degree required, along with related business experience and a proven record of achievement. A minimum of 5 years of relevant experience in the pharmaceutical industry is required, including at least 2 years' experience supporting compliant IT systems. Must have a strong understanding of 21 CFR Part 11 code. Must be able speak to all levels of the organization regarding questions or concerns around compliance issues. Experience with following types of computerized systems is a plus: ERP, LIMS, Quality management System (QMS), QC laboratory software and instrumentation. Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles.PI183221641

Keywords: Renaissance LLC, Lakewood , Manager, Validation Computer Systems, IT / Software / Systems , Lakewood, New Jersey