CSV Engineer

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce

We are currently looking for a CSV Engineer for one year.

Aim:
In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that: 
o Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities 
o Validation Master plans are up to date and established for all ongoing projects

Tasks:
· Assess and handle quality issues and corrections or CAPAS associated under the scope of CSV. 
· 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. 
· 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.

Competences:

Essential 
· Bachelor/master's degree in technical or natural sciences 
· 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) 
· Experience on validating software & hardware infrastructure (e-g: servers, network and software services). 
· A minimum of 4 years of working experience with CSV 
· Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
· Excellent 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 
· Business fluency in English

Preferred 
· German language 
· Experience in TrackWise system is a plus. 
· Experience on validating complex computerized analytical equipment 
· Basic know-how of Qualification requirements according to cGMP regulations 
· Basic know-how of quality assurance principles

If you are interested in hearing more about our CSV Engineer role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!