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Associate Engineer

Validation Engineer GMP

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for an Associate Engineer.

Keywords
  • B.Sc.
  • Validation
  • GMP
  • Projects

As Associate Engineer, you make sure that validation studies are executed conform site standards and Johnson & Johnson guidelines. The studies must meet the quality requirements. This function encompasses cleaning validation, hold time studies, temperature mapping and sterilisation validation of production equipment.
Responsibilities:
  • Participate in multidisciplinary projects as independent team member within Janssen Biologics;
  • Assessment of change controls and preparing of validation assessments;
  • Development of the validation strategy, preparation of protocols and execution of the internal review of protocols and reports;
  • Maintain and continuously improve the validation process,
  • Support in deviation investigations;
  • Establish and maintain contact with colleagues of other (large molecule) sites.

Profile

The ideal candidate has a B.Sc. in Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, Engineering, with 2-4 years relevant work experience in a Biotech/Pharma environment. You have experience with Validation Engineering (cleaning, mixing, sterilisation) and you are able to independently work on projects. You have feeling for GMP & compliance, you are accurate and you have a critical eye for details.
We are looking for someone who likes challenges, is collaborative and is keen on working within project teams.

Benefits

Salary: >3200
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Temporary project for 1 year
At least 3 days per week onsite, 2 days remote

Company profile

Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

Leiden site Technical Operations (TO) is part of the global Technical Operations organisation. TO manages the technology platform strategy within Leiden as well as across the other parenteral sites. The strategy is locally executed by TO. TO is responsible for validation and standardisation of processes and equipment within the Janssen Biologics site and manages Life Cycle Management (LCM) projects and improvement projects. They accomplish this through their broad technical competency, global reach, and local execution power. A job within the TO team is very dynamic and diverse.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.
Location Leiden
Associate Engineer

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