Janssen Biologics in Leiden, the Netherlands, is a leading production site within Janssen and part of Johnson & Johnson. At the Leiden site commercial pharmaceutical products & vaccines are being produced and new products are being developed and produced for clinical trials and early launch. At Janssen hardworking people are working together in a dynamic culture where innovation and a 'can do' state of mind are common good. We are proud of our Credo & diverse culture. The site is steadily growing and redefining to support our patients, while committing to the highest safety & sustainability standards!
The Make Asset Management (MAM) team is responsible for the introduction and maintenance of all assets. The Engineering department is part of MAM. The core tasks are design and introduction/modification of installations, equipment and facilities. To strengthen our engineering team we are looking for several enthusiastic and hardworking people.
There has never been a better moment to join Janssen Biologics!
Are you able to solve complex technical challenges within a multi-disciplinary team? Take accountability to define and align on the technical design and bring realization to a success? Are you a true teammate and have a hands-on mentality, thereby able to shape, lead and deliver? Then Janssen Biologics has a very ambitious and excite opportunity for you as
(Senior) Project Engineer MAM- Engineering
The project engineer is responsible for the design and implementation of technical solutions to pre-defined business needs. The project engineer represents the MAM-Engineering department in multidisciplinary project teams. In this role, you will coordinate all engineering fields and you will interact with internal and external partners to bring conceptual ideas to final solutions.
The project engineer has the overall accountability to realize solutions with the team. To meet the user expectations, open interaction is essential with the project team and partners. In this role the project engineer shows ability to meet the pre-requisites on Safety, Health, Environment, GMP and Reliability as it belongs to an installation or process to manufacture an Active Pharmaceutical Ingredient (API). You will become a domain specialist and need to be up to speed with all developments internally and externally on the utilities, equipment & processes.
The position is a very versatile and ambitious position with always multiple challenges in parallel! The role goes way beyond the technical focus: You’ll have a high interaction with all aspects of the company, whether Operations, QC, R&D or Quality, both local and within the JNJ enterprise.
Responsibilities & Accountabilities:
Act as Core Team Member in multidisciplinary project teams, representing all engineering fields and coordinate the complete engineering scope with other involved engineers.
Define the engineering scope at the start of a project together with the users and other engineering subject areas.
Develop multiple suitable solutions for technical challenges and rank/compare them on multiple criteria to come to the final solution.
Collect, verify and challenge customer demand and requirements of modification or equipment with the applicant, owners and users, and translate these into a scope description, user requirement and request for quotation packages.
Manage progress, quality and scope with external engineering firms, on site contractors and partners.
Coordination of modifications, equipment construction with construction supervisors and the business-unit organizations.
Check and approve drawings and calculations for design or construction and verify that design is in-line with the Dutch, European and Janssen Biologics standards.
Review change controls & participate in management of change meetings to represent engineering.
Own and maintain part of our internal engineering standards and link them with the internal J&J guidelines and global guidelines (ISPE).
Support in the development of the engineering department expertise, processes and key performance indicators.
Coach and support team members and peers in applying and developing our engineering standards.
Qualifications, Education, Skills & Experience:
Academic (Bachelor / Master) degree in a technical or life sciences field.
Minimum of 3 year working experience as engineer in a multidisciplinary environment (pharmaceutical area or equivalent).
Experienced in working within multidisciplinary teams.
Understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and maintenance & engineering (GMP, VCA, CE etc.)
Familiar with ISPE Guidelines and Standards.
Experience with EHS, FMEA/HAZOP standards & assessments.
High degree of accuracy, structured, flexible and customer oriented.
Initiative, independent and exploring person.
Flexible, can deal with changing priorities and stress resistant.
Practical technical understanding and conceptual thinking.
Critical analysis of user requirements & scope changes.
Clear and Concrete Communication.
Self-awareness & Adaptability.
Good knowledge of Office 365
Excellent communication skills both verbally and in writing in English and preferably also Dutch.
Since we strive for more diversity in the team, we do encourage female candidates to apply.
Netherlands-South Holland-Leiden- Organization
Janssen Biologics (7266) Job Function
Engineering Requisition ID
Open Positions from Johnson & Johnson Family of Companies