English
  • English
  • Dutch
  • German
CSV Engineer

Description

A Pharmaceutical client in Switzerland is searching for: CSV engineer for Industrial ITAim:In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that:- Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities- Validation Master plans are up to date and established for all ongoing projects Tasks: * Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts. * Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation) * Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards * Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners * Ensuring completion of CSV Periodic Review activities and assessment of the required corrective actions * Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups * Coordination and oversight of external subcontractors / software suppliers * Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV * Support Technical Services department KPI. * Ensure the CSV process related procedures and life cycle management are up to date according to international GMP standards and internal procedures * Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems commissioning, and qualification process are assessed and resolved. Requirements: * Bachelor/master’s degree in technical or natural sciences * Business fluency in English, German is a plus * Ability to work in a fast-changing environment * A minimum of 3 years of working experience within pharma or a biotech company * Experience on validating computerized manufacturing equipment (CSV context) * A minimum of 4 years of working experience with CSV * Experience on validating software & hardware infrastructure (e-g: servers, network and software services). * Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines * Ability to work under minimal supervision; Assess priorities and work well under pressure in a fast-paced environment * Ability to effectively work as part of a multidisciplinary, international team * Experience on validating complex computerized analytical equipment * Basic know-how of Qualification requirements according to cGMP regulations * Basic know-how of quality assurance principlesMichael Bailey International is acting as an Employment Business in relation to this vacancy.

CSV Engineer