Senior CSV Specialist - GxP Validation (Hybrid/Remote)

Carbogen AMCIS AG; Bubendorf; Hybrid; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

13th salary

Social security 100% covered

Bonus program

5 weeks holiday

Private travels insurance

Child day care contribution

Home office option

Zusammenfassung

CARBOGEN AMCIS AG in Bubendorf, Switzerland, is offering a Corporate Senior CSV Specialist position on a 2-year contract. The role may be based at Aarau or Neuland with flexibility to relocate within Switzerland.

You will partner on GxP IT systems, ensuring lifecycle management and data integrity across projects. The candidate brings 5+ years in validating GxP IT systems, strong cGxP knowledge, and a science degree.

Qualifikationen

• 5+ years in validation of GxP IT systems (ERP, LIMS, analytics) or in process automation.
• Solid knowledge of cGxP requirements for pharmaceutical companies.
• Degree in sciences or science-related field with relevant professional experience.
• Dynamic, motivated environment with strong infrastructure.
• Option to work partly from home.
• 5 weeks holiday minimum.
• Contribution to children's day care.
• Insurance covering private travels.
• 13th Salary, Social security to 100% covered by CARBOGEN AMCIS.
• Bonus Program

Aufgaben

• Advice and support for projects with Corporate GxP-relevant computer systems and support the system owners in lifecycle management.
• Review of qualification/validation documents for new and existing GxP-relevant computerized systems, software and electronic equipment steering according to applicable cGxPs.
• Review and evaluation of change applications, deviations and related CAPAs concerning validation, qualification and lifecycle management of computerized systems and data integrity.
• Risk assessment and risk mitigation of computerized systems related to data integrity.

Kenntnisse

GxP validation

Lifecycle management

Data integrity

Risk assessment

Team collaboration

Ausbildung

MSc/BSc in relevant sciences

Jobbeschreibung

CARBOGEN AMCIS AG in Bubendorf, Switzerland, is offering a Corporate Senior CSV Specialist position on a 2-year contract. The role may be based at Aarau or Neuland with flexibility to relocate within Switzerland.

You will partner on GxP IT systems, ensuring lifecycle management and data integrity across projects. The candidate brings 5+ years in validating GxP IT systems, strong cGxP knowledge, and a science degree.