Vacature Senior Associate Engineer

Bedrijfsomschrijving

At Johnson & Johnson Innovative Medicine, they are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure diseases inspires us. They bring together the best minds and pursue the most promising science. 

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.

   

We have a vacancy for a Senior Associate Engineer to work at Johnson & Johnson in Leiden. 

As a Senior Associate Engineer, you will be responsible for maintaining the life-cycle of Quality Control Development equipment and systems. Additionally, you are able to work in an ever-changing environment with short timelines. Also, as a Senior Associate Engineer, you are able to work closely with colleagues within QCD and together bring the team to the next level.

Your main tasks as a Senior Associate Engineer:

• Staying up to date with industry standards, regulatory guidelines and J&J compliance regarding equipment and (computerized) systems.
• Write and support in the design of various documents regarding qualification and validation of 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.

Job requirements

• Bachelor level in a life science study
• >2 years of laboratory work experience in a pharmaceutical environment
• GMP experience
• Experience and technical affinity with analytical equipment
• Experienced with laboratory management systems
• Strong affinity / knowledge of operating systems and instrument software
• Automation experience is seen as a bonus
• Highly proficient in spoken and written English

Terms of employment

We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. 

This concerns a secondment contract for 1 year via Yacht. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefits package in line with your seniority and the seniority of the position. Salary between 3700 and 4700 gross per month.

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Yacht via anastassia.blechko@yacht.nl of Anastassia Blechko. Of bezoek hun website onbekend.