Computerized Systems Validation Consultant

Adryan; Leiden; On-site; EUR 36,828 - 65,844; Full time

Benefits offered by this job

Company Car

Laptop

Telephone

Personal Training Budget

Job summary

Join a dynamic and rapidly growing organization as a Computerized Systems Validation Consultant. In this role, you'll develop validation strategies and ensure compliance in the pharmaceutical industry. You will be responsible for preparing critical validation documents and supervising a team of engineers. This position offers a competitive salary, an attractive bonus scheme, and excellent benefits, including a company car and personal training budget. Become part of a motivated team dedicated to innovation in life sciences!

Qualifications

• 5+ years of experience in computer validation in a GMP environment.
• Ability to work according to specific guidelines and rules.

Responsibilities

• Develop validation strategy and carry out validation activities.
• Prepare validation documents and reports.

Skills

Computer Validation

GMP Knowledge

Communication Skills

MS Office

Dutch Language

English Language

Education

Master's Degree in Technical or Scientific Field

Tools

MES

ERP

LIMS

QMS/eDMS

PLC

SCADA

Job description

Computerized Systems Validation Consultant

Adryan Leiden, South Holland, Netherlands

Computerized Systems Validation Consultant

Adryan Leiden, South Holland, Netherlands

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Senior Business Manager at Adryan - Direct support for your projects.

Computerized Systems Validation Consultant

Adryan is an internationally operating services group. From our offices in The Netherlands and Switzerland, we offer a full range of services for the (bio) pharmaceutical and high-end food industries. We are specialised in the areas of project management, engineering, CQV and compliance.

To strengthen the Adryan team in the Netherlands, we are looking for an experienced CSV Consultant. You will monitor the quality of processes, systems, equipment and/or software applications, used for research and production of medicines.

Key responsibilities:

• You develop the validation strategy and carry out validation activities on an R&D site or a production plant (Bio-Tech).

• You prepare ‘high level’ documents (Validation master plans, criticality analysis), protocols and scripts, procedures and reports, up to the final delivery.

• You may be conducted to supervise a team of validation engineers in the execution of validation activities.

• You strictly work according procedures and guidelines.

• You report on the progress of these validation activities to the project manager..

Job requirements

• You preferably have at least a master or engineer’s degree in a technical or scientific field, linked to life sciences.

• You have 5 years of experience with computer validation in a GMP environment and you know how to use some of its associated applications (ex.: MES, ERP, LIMS, EBR, QMS/eDMS, etc.).

• You have broad/general knowledge on computerized systems and maybe some automation (ex.: data security, data exchange, infrastructure, PLC, SCADA, MES-systems, ERP, etc).

• You are familiar with working according GAMP 5, and aware of current insights regarding 21 CFR-part11.

• You are able to work precisely and accurately and in accordance to specific guidelines and rules (ex. GMP, GLP).

• You have good communication skills at different (social) levels.

• You are self-reliant and organized, with a team spirit.

• You have experience with MS Office.

• You express yourself fluently in Dutch and English, oral and written.

Job offer

• A challenging position within a dynamic and rapidly growing organisation.

• Inspiring projects within our life sciences network

• A good salary, depending on education, knowledge and experience.

• An attractive bonus scheme and great benefits, such as a company car, laptop, telephone and a personal training budget.

• Being part of our motivated, dedicated and cooperative Adryan team.

Do you want to apply as CSV Consultant?

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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