CSV Engineer – 5793 URA

 

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a CSV Engineer on a 12 months contract based in the Bern area

 

The ideal candidate should have a technical educational background and have at least 3 years of experience working in Biotech or pharmaceutical industry on validating QC laboratory systems and manufacturing equipment's.

 

Main Responsibilities:

 

·       Assess and lead the CSV package(s) on an assigned project.

·       Taking accountability for the work to be produced by yourself and other colleagues that are under the assigned packages lead by this position.

·       Hands on: 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, Validation Reports.

·       Perform CSV periodic review of equipment and systems.

·       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

·       Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups

·       Coordination and oversight of external subcontractors / software suppliers when required · Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV

·       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 are assessed and resolved.

 

Qualifications and Experience:

Relevant working/residency permit or Swiss/EU-Citizenship required.

·       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 on validating complex computerized analytical equipment (QC Laboratory equipment)

·        Basic know-how of Validation requirements according to cGMP regulations

·       Basic know-how of quality assurance principles