Hays AG

Stellenangebot: CSV Engineer (m/f/d)

Bern Vollzeit

Jetzt bewerben

Über uns

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

Ihre Aufgaben

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
Ensure that Validation Master plans are up to date and established for all ongoing projects
Assess and produce the CSV package(s) on an assigned project. Taking accountability for the work to be produced
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
Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment or computerized systems commissioning, and qualification process are assessed and resolved

Ihr Profil

Bachelor or master’s degree in technical or natural sciences § Ability to work in a fast-changing environment¨
Experience within pharma or a biotech company
Experience on defining strategy and validating computerized manufacturing equipment (CSV context)
Experience on validating software and hardware infrastructure e.g. servers, network and software services
Experience with CSV § Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
Communication skills
Analytical thinking and problem-solving ability
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
Profound business English knowledge and German skills
Know-how of Qualification requirements according to cGMP regulations, basic knowledge of quality assurance principles