Quality Engineer

Oss | Quality Engineer | cGMP | Project Management | Documentation | Root Cause Analysis | SDLC | CVS |

Your new company

MSD is a leading company in global biopharmaceuticals with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. With 69,000 employees operating in more than 140 countries, MSD offers state-of-the-art laboratories, plants and offices that are designed to inspire their employees as we learn, develop and grow.

In Oss, there are two large production sites that are formerly known as Organon. The first location, Biotech Operations, produces novel biologic active ingredients (“drug substance”). Their activities are split between USP (cell culturing/microbiology in bioreactors up to 22,000 litres) and DSP (filtration and purification of product). The other location, Pharmaceutical Operations, focusses on the production, packaging and distribution of various end products (tablets and injectables) and birth control products.

Your new role

You are responsible for the qualification and validation engineering issues in the context of a System Administrator. In concrete terms, this means that you take care of the execution of all facets of the life cycle of computerised laboratory equipment such as a spectrophotometer or coulometer (e.g. configuration OS, Application and system with regard to data integrity and security).

Primary Responsibilities
  • Preparation of qualification protocols for computerised laboratory equipment;
  • Lead projects for (participate in) qualification of computerised laboratory equipment and Global IT projects; participating in Global project meetings, drafting documents and having tests carried out (acceptance of work carried out);
  • Drafting change requests arising from technical issues and executing changes correctly;
  • Sparring partner met MMD-IT & Global-IT m.b.t. Patching, Vulnerability Scans, Backup&Restore and IT troubleshooting;
  • Setting up / prototyping applications (roles, rights and responsibilities) using a Secure Desktop environment;
  • Performing Image Backups, Data Storage, Orphan data/testing into compliance (or monitoring these processes);
  • Involved in IT problems, managing root cause analyses (8-steps) to arrive at the right solutions;
  • Independently compiling all information, making proposals for improved procedures and instructions related to management, maintenance and operation of equipment;
  • Acting as a Subject-Matter Expert (knowledge carrier) for the qualification of computerised laboratory equipment (knowledge of SDLC/CSV and data integrity/security requirements) and supporting Lab investigation processes.

What you'll need to succeed

The ideal candidate would have completed a HBO or M.Sc. in Life Sciences or a relevant field. 3+ years working with the pharmaceutical or Biotech industry. Experience with and knowledge of project management. Experience working in a cGMP environment. You should be able to work in a team and independently. You are result-oriented, innovative and driven to improve. Excellent communication skills in Dutch and English is mandatory for this role.

What you'll get in return

Hays Detachering | This is a project that will start with a contract through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary and your travel expenses are covered.

What you need to do now

If you are interested in this role as Quality Engineer, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.

Klik hier om het privacybeleid van Hays te lezen, welke gedetailleerde informatie bevat over hoe we uw persoonlijke gegevens gebruiken en beschermen, en uw rechten in verband hiermee.

Overzicht

Contractvorm
Tijdelijk
Branche
Wetenschap, Research & Development
Locatie
Oss
Vakgebied
Life Sciences
Salaris
Competitive Salary + Travel Expenses Covered
Referentie:
1047563
Sluitingsdatum
24 Jun 2024

Spreek met een consultant

Spreek met Jordan Burke, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, H.J.E. Wenckebachweg 210

Telefoonnummer: 0630257804

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