Corporate Senior CSV Specialist

CARBOGEN AMCIS AG; Bubendorf; On-site; CHF 110,000 - 160,000; Full time

Benefits offered by this job

Dynamic work environment

Develop key competences

Some remote work

5 weeks holiday

Childcare support

Travel insurance

Private accident insurance

13th salary

Bonus program

Job summary

CARBOGEN AMCIS AG in Bubendorf, Switzerland, invites applications for Corporate Senior CSV Specialist (m/f/d) on a 2-year contract based in Bubendorf with flexibility to work at Aarau or Neuland.

You will advise on GxP IT systems, review validation documents, manage life cycle, assess risks to data integrity, and support system owners.

Qualifications

• At least 5 years of experience in validation of GxP IT systems (ERP, LIMS, analytics, or process automation).
• Sound knowledge of cGxP requirements for pharmaceutical companies.
• Degree in sciences with relevant professional experience.
• Business-fluent English.

Responsibilities

• Advise and support projects with Corporate GxP-relevant computer systems and support system owners in life cycle management.
• Review qualification/validation documents for GxP systems, software and electronic equipment in line with cGxP.
• Review and evaluation of change applications, deviations and CAPAs concerning validation, qualification and life cycle management of computerized systems and data integrity.
• Risk assessment and risk mitigation of computerized systems related to data integrity.

Skills

GxP IT validation experience

cGxP knowledge

English (Business fluent)

Education

MSc/BSc in computer science/chemistry/process engineering

Job description

Corporate Senior CSV Specialist (m/f/d) for a 2 years contract

We are currently offering an interesting opportunity as Corporate Senior CSV Specialist (m/f/d) for a 2 years contract at our location inBubendorf, Switzerland, with flexibility to be based at one of our other Swiss locations, such as Aarau or Neuland. If you are looking for a varied and exciting new professional challenge, we are happy to receive your application.

Your responsibilities:

• Advice and support for projects with Corporate GxP-relevant computer systems and support the system owners of computer systems in life cycle 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 life cycle management of computerized system and data integrity
• Risk assessment and risk mitigation of computerized systems related to data integrity

Your profile:

• At least 5 years of experience in the validation of GxP-relevant IT systems such as ERP, LIMS, analytics systems or in process automation
• Sound knowledge of cGxP requirements for pharmaceutical companies
• Degree in sciences (MSc/BSc in e.g. computer science, chemistry, process engineering) or a science education with relevant professional experience
• Business-fluent English

Your benefits:

• A dynamic highly motivated work environment and a high value infrastructure
• Possibility to enhance, increase and further develop you key competences
• Option to work partly from home5 weeks holiday at minimum
• Contribution to children's day care
• Insurance covering private travels
• Privat accident insurance
• 13th Salary, Social security to 100% covered by CARBOGEN AMCIS
• Bonus Program

We look forward to receiving your application!