First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Contract

Location: Switzerland

Discipline: Information Technology

CSV Consultant Biologics - Contract - Onsite

Proclinical is currently supporting a Global Biopharmaceutical manufacturing partner to recruit a CSV Consultant: Biologics (m/f/d). In this position you will be responsible for the generation and execution of the validation of the computerized systems on process engineering equipment and facilities, including MES.

You are responsible to follow the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle of the plants, as well as make a contribution to the ongoing optimization of processes, facilities and internal procedures.

Responsibilities:

Preparation of commissioning and validation documents for new systems, as well as the supervision of conversion, expansion and new construction projects. This is broken down into CSV activities on new construction projects for critical systems and SLC support for all systems after going live
Supervision of deviations, changes (GEP and GMP), and CAPAs
Coordination of CSV executions with internal groups, as well as external service providers and suppliers
Responsible for the presentation of CSV documents during audits and inspections
Scheduling and reporting of CSV activities
Following the alignment of the CSV strategy with the QA CSV for all Biologics scope
Contribution in the review and amelioration of all CSV documents

Key Skills & Requirements:

Required: minimum 7 years in CSV in Biotech or Pharma (not Medical Devices CSV experience)
Bachelor / Master / Diploma from a technical school (HF) / university of applied sciences (FH) or university in a technical field
Significant experience in a regulated environment with regard to Computerized System Validation (CSV)
Good knowledge of Microsoft Office and Delta-V is required
Knowledge of KNEAT, COMOS (plant engineering software solution), DMS, TrackWise and SAP is an advantage
Fluent in English, German language skills are advantageous

If you are having difficulty in applying or if you have any questions, please contact Sheridon Lloyd on +41 61 563 1243.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#IT&DigitalTransformation

Related jobs

Technical Project Manager

Salary

Highly Competitive Salary

Location:

Lexington, USA

Proclinical is seeking a dedicated Project Manager to lead IT projects within business applications and IT infrastructure. This is a contract position located in Lexington, MA.

Anderson Maldonado

Apply

Backend Developer/DevOps (w/m/d) e-Health

Salary

Highly Competitive

Location:

Basel, Schweiz

Proclinical sucht einen Backend-Entwickler/DevOps für unsere offene eHealth-Datenplattform.

David Mihaljevic

Apply

Power BI Developer

Salary

Highly Competitive Salary

Location:

Bern, Switzerland

Proclinical is seeking a Power BI Developer who is passionate about data and analytics. This is a permanent position located in Bern, Switzerland.

Jana Van Zyl

Apply

Senior SAP FICO Consultant - Zurich, Switzerland

Salary

Up to £0.00 per annum

Location:

Zürich, Schweiz

Proclinical are currently supporting is a global management and technology consulting group as they are looking to recruit a Senior SAP FI/CO Consultant in Zurich, Switzerland.