Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
We are recruiting a Recipe Management Specialist to work within the Execution Systems department to support this new facility now and in the future.
MAKE Asset Management (MAM) organization:
The MAM organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems activities. This occurs in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing & Technical Organization (MTO) and in conjunction with key partners, to create one integrated internal/external network.
Job Summary:
Execution Systems (ES) is a dedicated team of enthusiastic and skilled Automation professionals with various technical expertise, responsible for the (support of) implementation, validation, qualification and maintenance of the ISA-95 level 1 and 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for the Leiden manufacturing facility. We ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.
In this role you will work in a dedicated team focused on implementing a standard recipe-based product management processes across all business units at our Leiden manufacturing facility. As a Recipe Management Specialist, you are responsible for creating and maintaining recipe and master data into manufacturing and control systems throughout product lifecycle.
The responsibilities and the impact YOU will have:
- Creating and maintaining recipe and master data and Master Recipe into manufacturing and control systems and manufacturing execution system (MES) throughout product lifecycle.
- Completing or participating in investigations (Events/CAPA's) for deviations related to ES systems.
- Participate in compliance inspections for topics related to ES systems.
- Work across platform with other Recipe Management Specialists, to manage and develop site recipes.
- Work with business specialists (Production, PDMS and Technical Operations) to define requirements for new and existing recipes.
- Coordination of tasks to ensure timely delivery.
- Monthly reporting of tasks completed, and support provided.
- Electronic batch tests on shop floor.
- Go Live and after care.
- Evaluation, solving and documentation of all MES related issues.
- Develop, implement and manage department business processes.
- Leading and driving improvement initiatives to support department objectives, using improvement tools like A3 thinking, lean 6Sigma or JJOS.
- Other duties as required.
Qualifications
We would love to hear from YOU, if you have the following essential requirements:
Capabilities identified as priority for our Workforce of the Future are:
- Digital & Technology
- Change Leadership
- Critical Thinking & Problem Solving
- Process knowledge & expertise
- End to End mindset
Qualifications:
- A technical education/ degree in Engineering, Science or relevant engineering subject area is preferable, at Bachelor level or higher.
- Demonstrated experience working in a similar role with a required minimum of 3-5 years.
- Experience in industrial automation technology and standards, validation and/or recipe management in pharmaceutical industry is preferred.
- Experience in a GxP regulated environment and proven knowledge of current Good Automated Manufacturing Practices (GAMP).
- Expertise in MES (Werum PAS-X preferred) and good knowledge in MES integration with ERPs and automation systems required.
- Understanding of production processes.
- Experience in developing master batch records (MBRs) to reflect the manufacturing process and master recipes required.
- Knowledge of Process Excellence tools (Lean, Six Sigma) preferred. Green or Black Belt Certification in Lean or Six Sigma is preferred.
- Proficient in the preparation of technical reports and presentations.
- Demonstrated experience in the development, review and implementation of business processes and procedures.
Key Competencies:
- Good organizational skills, including experience organizing self and others, coordinating and initiating work arrangements with minimal direction and the capacity to work under stress.
- Demonstrated high level communication skills and excellent interpersonal and relationship building skills including the ability to work independently, flexibly and collaboratively, and to negotiate effective business outcomes. English required and Dutch preferred.
- Ability to create a path forward even if the solution is not yet clear or there is no standard process.
- Decisive, pragmatic and persevering with a can-do mentality.
This is what awaits YOU at J&J:
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Career opportunities and continuous personal and professional development in areas of technology and leadership.
- Personal Development Plan – such as access to further education & training, mentoring and coaching, development opportunities on-the-job or through exciting projects.
- Be part of a strong global network of talent and expertise, with opportunities to learn or move to different cultures and work environments.
- Many employee benefits.
- We are an equal opportunities employer.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.