Project Engineer C&Q

Janssen Biologics in Leiden, the Netherlands, is a leading production site part of Johnson & Johnson where commercial pharmaceutical products & vaccines are being produced and new products developed. Our teams are working together in a dynamic environment where innovation and a 'can do' state of mind are common good. The site is steadily growing to support our patients, while committing to the highest safety & sustainability standards. We are proud of our Credo and diversity and this role offers the opportunity for a hybrid working pattern, 3 days in the office and 2 days working from home. The Make Asset Management (MAM) team introduces and maintains assets in the site. As part of the MAM organization, the Engineering team designs, introduces/modifies installations, equipment and facilities. To build up and strengthen our team, we are looking for several hardworking and dedicated people. This is the best moment to join us! Function description: We are looking for an enthusiastic Project Engineer C&Q in an annual contract position to join the Engineering Qualification team that, within the Engineering department, is responsible for the commissioning & qualification of installations and equipment working as part of a multidisciplinary project team. In this role you will be involved in the core tasks of the Engineering department meeting and securing the cGMP requirements during systems introduction. Responsibilities & Accountabilities: The Engineer commissioning & qualification is primarily responsible for ensuring that validation studies are carried out in accordance with cGMP guidelines, the department standards and Johnson & Johnson guidelines and that they meet the desired quality requirements. It concerns qualification of Clean-rooms (PQ), Utilities (I/OQ and PQ) and Equipment (I/OQ). Daily coordination of the activities and questions for the Qualification team. Coordinating and organizing external parties for commissioning & qualification. Operate as an independent team member or department representative in multidisciplinary projects. Assessing change controls and making validation assessments. Establishing the validation strategy, drawing up validation plans, protocols/reports writing and approval. Training and guiding colleagues for validation activities. Maintain and continuously improve the validation process. (Periodically) checking and updating the procedures, protocols and standards for Engineering commissioning & qualification (periodic review). Providing support with deviations. Acting as a supervisory & qualification expert from Engineering during internal and external audits and inspections. Maintaining contacts with colleagues from other (large molecule) sites. Qualifications HBO education (preferred Wtb); At least 2-3 years of meaningful work experience in the (bio-) pharmaceutical industry; Familiar with cGMP, ICH, FDA and EMA Guidelines and standards; Team player who can also develop a team; Accurate, structured, flexible and customer focused; Good communication skills in English (both oral and written); Experience with cGMP inspections, process excellence and project management is an advantage. Primary Location Netherlands-South Holland-Leiden- Organization Janssen Biologics (7266) Job Function Engineering Requisition ID 2206058477W