Vacature Operations Engineer

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity Posters and GINA Supplement.

• Location Leiden, South Holland, Netherlands

JOHNSON & JOHNSON / JANSSEN / GENE THERAPY FACILITY / OPERATIONS IS LOOKING FOR AN OPERATIONS ENGINEER
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without diseases. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and hearts to pursue the most promising science into life changing products for patients around the globe. One of the key focus area's for Janssen in Leiden is the development and production of Gene Therapeutic products to cure chronic diseases.

At the Janssen site in Leiden (located at the Bioscience Park), we work with more than 2400 talented and multi-skilled people in 5 different business units. We produce different products and pioneer solutions to deliver better health. This vacancy is for Business Unit 2: The Gene Therapy Facility (GTF).

The GTF is Janssen's state-of-the-art GMP manufacturing facility from which we launch and grow new and innovative Gene Therapeutics products. The facility has two manufacturing suites. In suite 1 we produce Drug Substance (e.g. cell & virus cultivation and purification processes). In suite 2 we produce Drug Product (e.g. Fill & Finish processes) for the final product.
Both production suites in the GTF are currently in the final stage of preparation for Phase 3 and commercial production to accommodate the transfer of new products to the GTF per 2024.
Are you excited to set up a plant with new equipment and scale up the processes within a global company? Do you get energy from working together and contribute to improving the life of patients?
Location : Leiden, Nederland
Business unit : Gene Therapy Facility
Department : Operations (Drug Substance & Drug Product)
Function : Operation engineer19)
Contract : Full Time (0.8-1.0 FTE)
Start date : Q2 2024

The operations department is responsible for on-time manufacturing and delivery of the planned batches against the high-quality standards and safety and compliance regulations that are applicable for Janssen's product portfolio for Gene Therapeutic products. The operation department consists of Manufacturing operators and specialists. The Manufacturing Operators are responsible for the actual on-time production, filling, and delivery of the products.
The General Operations Team consist of Manufacturing specialists, GMP specialists, a planner and Operations Engineers with in-depth operation knowledge and are responsible for GMP, inspections, planning and project support within the operation department and the other departments.
In your role as Operation Engineer, you will support and be involved in all Operations projects for the GTF and are the representative for Operations department in projects within the GTF departments. You be the Single point of contact (SPOC) and work closely with all the departments within the GTF to ensure that the operations knowledge is transferred to the projects. In parallel with these activities, you are responsible for coordinating the CI/BI process within operations, the distribution of the recourses in Operations for projects and the network between all departments in and out the GTF.
During the preparation phase (the transfer of new products to the GTF per 2024) you will work mainly on getting to know the processes and being the SPOC for operations within the projects. You will also participate in manufacturing readiness initiatives of the new equipment and processes, including process documentation and qualification.

Responsibilities and the impact YOU will have:
As an Operations Engineer, you will be responsible for:
• Having an overview and the knowledge of the status of the process.
• Taking part in activities related to the production support of cGMP batches in the launch facility. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing and deviations.
• Detecting, and solving problems and communicating possible abnormalities. Acute troubleshooting when problems occur during production.
• Accurate completion of documentation such as batch records, logbooks, etc.
Project member or -lead
• Writing the business cases and need statements for projects for the Operations department.
• Delivering projects that are operational ready for the GTF operations department.
• Working continue to make a network in and out the GTF.
• Identifying and participating in improvement projects like CI's and BI's.
• Supporting process excellence activities to continuously improve the work as well as personal skills.
• Supporting the General Operations team as back up Supervisor

If you meet the following Job requirements, we would like to hear from YOU:

• Bachelor's degree or higher in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
• 3-5 years' experience in a biotechnology or biopharmaceutical industry environment.
• Experience with cGMP environment and EHSS standards is required.
• Experience in Lean Methodology, certified Yellow Belt, preferably Green Belt.
• Good communication in Dutch and English, both verbally and in writing.

• Resilience: can deal with challenges, changes, and unexpected setbacks in a positive and meaningful way.
• Stress-resistant: Is realistic in what they can and cannot achieve within a certain timeframe, dares to say 'no' when things are not feasible or do not appear to be feasible and suggests how and when it can be done. Sets deadlines, divides tasks, and escalates clearly and timely if needed.
• Collaboration: Actively connects with peers/colleagues/stakeholders/external partners and makes use of these connections within the organization.
• Communication: Stimulates open communication and can adapt communication style to the situation.
• Decisiveness: Supports and takes decisions based on facts, data, and the transcending angle.

This is what awaits YOU at J&J:
• An opportunity to be part of a global market leader, with a strong global network of talent and expertise, with opportunities to learn or move to different cultures and work environments.
• A dynamic and inspiring working environment with career opportunities and continuous personal and professional development in areas of technology and leadership.
• A Personal Development Plan - such as access to further education & training, Insights Discovery training, mentoring and coaching, development opportunities on-the-job or through exciting projects.
• Many employees benefits like:
- Flexible working arrangements with J&J Flex, enabling you to work from home;
- Provides a middle wage pension plan. It is company sponsored with an employee contribution of 4%.
- 36 days holidays (based on full-time employment);
- a monthly allowance of 20 EUR for a subscription to a sport center and a bike plan.
- Global Parenteral Leave policy offering 12 weeks of leave (birth/parenteral, adoption/foster care and parenteral) at 100% pay to parents.

Our Commitment to Diversity, Equity, & Inclusion:
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"!

If you are interested in this position and you are the enthusiastic experienced Manufacturing Engineer who is ready for a new challenge, respond to this position. For questions about this position, please contact (0031-6-5239 6669) or Eerenst Kluter.
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/.

• Supply Chain Manufacturing - Manufacturing Product & Packaging Operations

We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.

Except as specifically requested by J&J China or legally required, please avoid submitting information in your application which may be deemed as sensitive personal information, which includes biometrics, religious belief, specific identity, medical health, financial accounts, whereabouts, as well as information of minors under the age of fourteen (14), and other information that the breach or illegal use of which may easily lead to the infringement of an individual's personal dignity or harm to personal or property safety.

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You may contact the Personal Information Protection Officer of the J&J China at to exercise your relevant rights to the overseas recipient, including access, correct, copy, or delete your personal information.

Types of Personal Information Provided

Basic Information : Name, Birthday, Ethnicity, Gender, Nationality, Headshot;

Contact Information : Address, Phone Number, Email;

Academic & Professional Information : Occupation, Position, Employer, Work Experience, Educational Background, Degree, Training Records.

Procedures to Exercise Your Rights

You may contact the Personal Information Protection Officer of the J&J China at to exercise your relevant rights to the overseas recipient, including access, correct, copy, or delete your personal information.

Except as specifically requested by J&J China or legally required, please avoid submitting information in your application which may be deemed as sensitive personal information, which includes biometrics, religious belief, specific identity, medical health, financial accounts, whereabouts, as well as information of minors under the age of fourteen (14), and other information that the breach or illegal use of which may easily lead to the infringement of an individual's personal dignity or harm to personal or property safety.

In this Employee Consent Letter, "J&J China" means the company in the Johnson & Johnson Family of Companies which you applied for, and "Johnson & Johnson Family of Companies" means Johnson & Johnson Services, Inc.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

Functie:	operations engineer
Startdatum:	31-01-2024
Ervaring:	Ervaren
Educatielevel:	WO
Contracttype:	Freelance
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Johnson & Johnson via onbekend of onbekend. Of bezoek hun website onbekend.