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Sr. Associate Engineer QC Equipment

Vacancy number: A2400006
Janssen Vaccines & Prevention - Leiden (Nederland)

For our client, Janssen Vaccines & Prevention, we are looking for a Sr. Associate Engineer QC Equipment.

Keywords

BSc. / HBO
GMP
Validation
Equipment
Qualification

Profile

As Sr. Associate Engineer you will be responsible for maintaining the lifecycle of QCD equipment and systems. You have to stay up to date with industry standards, regulatory guidelines and J&J compliance regarding equipment and (computerized) systems.
Your responsibilities will be:

Write and support the design of qualification and validation documents regarding equipment and automated systems (URS, CAR, VA, IQ, OQ, PQ, TRG);
Execute equipment/systems qualification and validation activities consistent with established and evolving regulatory and company requirements;
Execute qualification, calibration, maintenance of equipment and systems;
Ensuring appropriate resolution and documented justification for any issues deviations/non- conformances encountered during qualification, validation and maintenance of equipment and systems;
Make sure preventative maintenance, calibration of testing equipment is up to date and oversee the inventory of validation supplies;
Decommissioning of qualified/validated equipment and systems through Change Control procedures;
Take up or assist in (improvement) projects regarding equipment and automated systems within QC Development;
Troubleshooting of equipment and systems in case of malfunction.

Who we're looking for

For this role we are looking for BSc. / HBO candidates with at least 3-5 years experience in a similar position in a pharmaceutical (GMP) environment. You have experience and technical affinity with analytical equipment and with laboratory management systems. Automation experience is seen as a bonus. Additionally, you have strong affinity or knowledge of operating systems and instrument software. As a person, we are looking for a candidate that is a technical problem solver, who is able to prioritize his/her own work and that has great interpersonal skills. Are you the candidate we are looking for?

Department

The Quality Control Development (QCD) group within the Analytical Development (AD) Department is responsible for release and stability of our products from early stage up to commercial and all related processes ensuring efficient, effective, and compliant production and testing of our products.
The QCD Labs group focuses on supporting production and laboratory activities with:

Inspection, release and change management of incoming production raw materials and laboratory chemicals.
Sample and Material receipt, handling, storage and forwarding.
Maintaining controlled state of production clean room and production utilities by environmental and utility monitoring programs.
Coordination of Release and Stability testing and Outsourcing Coordination.
Internal release and stability testing including culturing of cells.
Ensuring the availability and maintenance of qualified equipment used in the laboratories.

Company profile

Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.

Additional vacancy information

Reference	:	A2400006
Contract	:	Temporary contract with CLS Services
Education	:	HBO/BSc.
Employment terms	:	Contract for 1 year, extention possible. Days of leave: 36 See here our other employment terms for this vacancy
Publication date	:	1-2-2024
Location	:	View location with Google Maps
Contactperson	:	Claudia Erwich-Faaij
		+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and secondment of people with a background in chemistry & life sciences.

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