CSV Engineer in Schaffhausen

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

Essential duties:

Assess and produce 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 commissioning, and qualification process are assessed and resolved.

Qualifications and Skills:

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 in validating computerized manufacturing equipment (CSV context)
Experience in 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 and German
Experience in 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

For our client, an international company based in Bern, we are looking for a motivated CSV Engineer.

General Information:

Start date: ASAP
End date: 31.12.2024
Extension: possible, to be discussed
Workplace: Bern
Workload: 100%
Home office: 3 days on-site presence is required; on demand it may increase

Key Responsibilities:

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

Essential duties:

Assess and produce 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 commissioning, and qualification process are assessed and resolved.

Qualifications and Skills:

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 in validating computerized manufacturing equipment (CSV context)
Experience in 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 and German
Experience in 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

kontaktiere uns.

wir sind da um deine Fragen zu beantworten.

LF

Luca Furler

+41 58 201 55 50
Basel Professionals IT & Life Sciences

der Bewerbungsprozess.

Erfahre wie der Bewerbungsprozess aussieht. Finde heraus wie wir dir helfen werden, diesen Job zu bekommen.

1 von 8

mit randstad bewerben.

Wir werden deine Bewerbung überprüfen und sehen, ob du zu diesem Job und Unternehmen passt.

2 von 8

Wir werden dich kontaktieren.

Unser Consultant wird dich zu einer passenden Zeit anrufen und mit dir deine Bewerbung und deine Karriereziele besprechen.

3 von 8

deine registrierung.

Falls du noch nie mit uns zusammengearbeitet hast, brauchen wir ein paar Informationen um herauszufinden, ob du in der Schweiz arbeitsberechtigt bist.

4 von 8

background check.

Um sicherzustellen, dass du der perfekte Kandidat für diese Rolle bist, werden wir alle relevanten, von dir zur Verfügung gestellten Referenzen kontaktieren.

5 von 8

der perfekte job für dich.

Unser Expertenteam wird entweder ein Vorstellungsgespräch für die Stelle arrangieren, auf die du dich beworben hast oder passende alternativen vorschlagen.

6 von 8

das interview.

Wir werden sicherstellen, dass du vollständig für dein Interview vorbereitet bist und weisst, was dich erwartet. Viel Glück!

7 von 8

dein start im neuen job.

Gratulation! Du bist bereit für deinen neuen Job. Unser Team wird sicherstellen, dass du vollständig vorbereitet für deinen ersten Arbeitstag bist.

8 von 8

beginne deinen neuen job.

Nachdem du deine neue Herausforderung begonnen hast, werden wir dich kontaktieren und sehen, wie es dir geht und wie wir dich in deiner neuen Rolle unterstützen können.

ähnliche jobs.
Kontakt

Luca Furler

Referenznummer

20008

Beschleunige die Bewerbung, indem du dein Profil teilst

Job Details

For our client, an international company based in Bern, we are looking for a motivated CSV Engineer.

General Information:

Start date: ASAP
End date: 31.12.2024
Extension: possible, to be discussed
Workplace: Bern
Workload: 100%
Home office: 3 days on-site presence is required; on demand it may increase

Key Responsibilities:

Firma: Randstad AG

Bewerben