CSV Engineer

Doorsturen
 
  • Aanbod € 80,000 - € 90,000
  • Functiegroep IT
  • Dienstverband Fulltime
  • Vacaturenummer 8898900
  • Locatie Oss
  • Contract Detachering via YER
  • Branche Medical & Health

Over deze vacature

Within MSD a global program was started to protect the company against cyber treats and natural disasters. This ERMD (Enterprise Resilience Modernization and Data Integrity) program has to ensure we are better protected and become more resilient when something happens in this area.

General requirements are defined for systems on Security, Modernization and Data Integrity. A system inventory shows that a large amount of automation systems need modifications to comply with the ERMD requirements.

Functie

A Taskforce identified several projects. 25% of the projects require equipment replacements or upgrades and 75% are automation driven. We will team-up approx. 10 project teams to execute the automation driven projects.
The teams will determine the project scope to upgrade or replace the automation. After approval by a central board a strict schedule will be followed to document, upgrade or replace and test the automation to meet the final integration date.

Every project team exists of a Project Leader, Computer Systems Validation Engineer, Design Engineer Automation, Quality Officer and production representatives. A centralized Project Services team will support the teams with scheduling, finance and document management.

Bedrijf

n 1923, Saal van Zwanenberg started Organon, where at that time pancreatic porcine insulin was purified. It was the start of over 90 years of innovative pharmaceutical production in Oss. Approximately 1,500 colleagues currently work on the production and development of medicines at two locations.

Quality Operations (QO) at MSD Biotechnology operations Oss has the following sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents HUB. The QO Department must ensures adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of MMD products according to MMD Policies, Guidelines & Procedures and regulatory requirements by appropriate oversight and monitoring.

Provides day to day support for Biotech Operations, raising concerns if needed or directing users to do so. In co-operation with functional areas and in line with quality procedures and guidelines, support the handling of deviations, including implementation of CAPA’s. Partner with internal and global groups for technical issues resolution related to investigations or system issues.

Aanbod

We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to MSD.

Our benefits are very competitive and designed around your preferences:

  • A competitive salary depending on experience
  • Extensive set of tools to drive your career, such as a personal development budget, training and coaching
  • Healthy work-life balance

Profiel

For these project teams we are looking for Computer Systems Validation Engineers:

  • Proactive and result oriented team player
  • Familiar with process Automation
  • > 5 year experience with Validation in Life Science / pharma
  • Writing the Qualification Plan, Requirement Specifications, User Acceptance test protocol and Qualification Report will be part of your work
  • You are responsible for compliance with the ERMD requirements and the validated state
  • Interpretation of the compliance will be agreed with the Quality Officer
  • Reporting progress deviations to the project leaders
Doorsturen