Sr. Engineer Life Cycle Management
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for a Sr. Engineer Life Cycle Management.
Under the direction of the PM Manager, you manage most aspects of multiple projects or initiatives. This role interfaces directly with other facility and corporate functional groups to ensure that goals and objectives are met within GMP/ISO compliance and product design changes are addressed appropriately. You are accountable for lifecycle project management including leading projects to improve our product offering as required by business objectives of assigned product platforms. Additionally, you review and approve potential process changes for their effect on product performance. You lead resolution of product/production issues as assigned, as well as multifunctional, cross departmental projects and initiatives geared towards achieving process improvements, cost reductions, new process/product introductions and quality improvement.
- Supports the R&D and PM NPI group with executing new process development deliverables in order to launch high-quality, compliant new products into production while meeting time, cost and margin targets;
- Monitors and supports new product processes until stabilized, and fully transferred into production;
- Manages and executes projects and/or programs of moderate to high level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met.
- Provides project management guidance and business tools, utilizing a systematic approach to project execution;
- Prepares management reports and presentations;
- Effective project planning and structure;
- Develops imaginative strategies for the efficient completion of projects;
- Sets the engineering standard and direction for the group;
- Leads the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management;
- Develops new ideas within incoming processes;
- Coordinates phases of work with other departments within the company and other divicions.
- Participates in GMP audits regarding equipment recording and machine performance.
- Coordinates communications and interfaces with end users, machine manufacturers and/or suppliers.
- Writes, develops and implements validation procedures.
- Reviews and analyzes data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non-normal results.
Who we're looking for
The ideal candidate has a Bachelor’s Degree in an engineering discipline and 6 - 8 years work experience in engineering in a medical device environment. You have experience in a manufacturing environment developing manufacturing standards and in short and long-term project management. This position will involve periodic entry in a clean room production environment which requires certain preparation and gowning practices.
- Strong Organizational, interpersonal, oral and written communication skills (EN is a must have, Dutch is a plus);
- Ability to prioritize multiple commitments and technical problem-solving duties;
- Ability to shift priorities according to changes in department/facility needs and open to different ideas/approaches;
- Ability to periodically interact with associates and processes in a clean room environment.
- Understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
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.
Additional vacancy information
|Contract||:||Projectmatig dienstverband met CLS Services|
|Employment terms||:||Project for 6 months, contract can be extended after first 6 months.|
Salary: > 4250
Days of leave: 25 + 11
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.