IT Computer Systems Validation (CSV) Engineer

XDES is specialist in recruitment van technisch personeel. Job DescriptionIT Computer Systems Validation (CSV) Engineer – Cell Therapy Manufacturing 
Reporting into the Director of IT for the Leiden Cell Therapy Facility (CTF), the IT CSV Engineer will lead the Computer System Validation function for the Leiden Cell Therapy Facility during the startup phase. 
Besides in-depth knowledge and experience with CSV, the candidate must possess excellent communication skills, strong can-do attitude, flexibility, helicopter view and must be savvy working with both technology and business partners across the international organization in a collaborative way. 
Job duties include: 
Write and review of Computer System Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols;Develops complete understanding of BMS policies and procedures related to all aspects of computer system validation;Liaises with cross-functional SMEs in developing and promulgating the computer system validation methodology for the Cell Therapy function;Participates actively with other groups to analyze and address process deficiencies. Work collaboratively with peers within the Validation, Manufacturing, Manufacturing Engineering and Quality groups;Assists in generating responses to audit observations;Effectively manages workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies;Ensures alignment with BMS directives and industry guidelines on Digital Plant issues;Provides validation subject matter expertise (SME) in the Digital Plant environment and contributes to multi-function teams, advises personnel on validation matters, and defends their work before regulatory agencies and auditors;Leads, in addition to operations support, internal compliance and/or efficiency improvement efforts within department for more complex processes;Provides technical expertise to management and lower-level professionals, providing an unusually high level of information and expertise not readily available from other sources.
Job RequirementsKnowledge of engineering and science generally attained through studies resulting in a B.S. in Engineering, a related Automation discipline, or its equivalent;A minimum of 10 years relevant experience in the biopharmaceutical industry or its equivalent;Knowledge of Quality principles, computer system development lifecycles, and QA methodologies, such as ISO 9001;Knowledge of and experience with the S88 batch control standards and the and ISA-95 manufacturing plant levels;Strong knowledge of computer and IT concepts and their potential effects on compliance in a GMP environment;Understanding of data integrity requirements and implementation;Good technical understanding of IT Infrastructure, manufacturing execution systems (such as Syncade), process automation systems (such as DeltaV), Laboratory Information Management Systems (such as Labware), Building management Systems and integration with enterprise systems;Excellent project management, communication, and technical writing skills are required;Mastery of SOPs, cGMPs and compliance requirements and regulatory guidelines and the technical acumen to work and manage within a regulatory environment;Strong knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing;Must be able to influence others in matrix environment;Resilient profile with the ability to deliver in an ambiguous environment;Ability to engage and manage multiple stakeholders to achieve the objective;Curious with learning agility;Operationally excellent.
Salary and BenefitsThis is a responsible job with good employment conditions.Contact UsContactpersoon voor deze functie als IT Computer Systems Validation (CSV) Engineer is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: joost@xdes.nl Kenmerk: 10881.