Equipment Engineer General / USP LVV

J&J Family of Companies; Sassenheim; On-site; EUR 45,000 - 71,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson's LV Operations is seeking an Equipment Engineer to support General Equipment and Upstream Processing. You will join a cross-disciplinary team ensuring safe, compliant, and reliable production on the LVV facility in Sassenheim.

Responsibilities include system ownership, troubleshooting, maintaining validated state of equipment, and collaborating with Operations, Maintenance and Engineering to improve process reliability and efficiency in GMP settings.

Qualifications

• Bachelor’s degree in biotechnology, biochemistry, biomedicine, or process technology.
• 3-4 years’ experience in biotechnology/biopharmaceutical manufacturing.
• Knowledge of fridges/freezers (TCSUs), cell culturing, incubators, and single-use bioreactor control.
• Experience with cGMP environment and EHSS standards; Annex 1 preferred.
• Willing to troubleshoot 24/7 on a rotating schedule.
• Fluent English (B2) and Dutch (basic).

Responsibilities

• Identify, plan and control changes for system and process robustness (0-3 months timeframe).
• Lead/owner business processes and projects that are system or facility related.
• Ensure the production equipment is validated, documented, maintained, and capacity meets planning.
• Collaborate with Operations, Maintenance and Engineering across sites.
• Generate process equipment reports and KPI; status overview (uptime, downtime, etc.).
• Initiate and execute test protocols to improve the system or process.

Skills

GMP knowledge

Analytical reasoning

English communication

Dutch (basic)

Education

Bachelor’s degree in biotechnology/biochemistry/biomedicine/process technology

Tools

Fridges/Freezers (TCSUs)

Cell culture

Single Use Bioreactor control

Wave bioreactors

Upstream Processing (USP)

Job 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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Professional

All Job Posting Locations:

Sassenheim, Netherlands

Job 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/.

The Lenti Viral Vector (LVV) Operations Facility: Janssen Biologics B.V., part of Johnson & Johnson, has launched a state-of-the-art production facility in Sassenheim. In this new facility lentiviral vectors are produced, which are used in the CAR-T treatments for multiple myeloma. The Centre of Expertise (CoE) is an essential operations group in the LV Operations.

The CoE is a critical team in the direct support of Operations when it comes to technical process and GMP support. The CoE is key in clear translation of the developed process to a workable process and environment for the shop floor. The CoE always works against the high-quality standards and safety and compliance regulations that are applicable for LV manufacturing. CoE is responsible for supporting the production teams with specialized and in-depth knowledge and skills in our production processes, cGMP, Annex 1, Digital Technology, Materials and Single Use Items. The Centre of Expertise (COE) is a team of around 15 specialists.

The CoE team is one of 3 departments within the LVV facility and working with the Operations Department (OPS) which is responsible for the safe, compliant, efficient, and on time production and delivery of the batches (USP, DSP, F&F) and the New Product Introduction (NPI) team to introduce new products or implement big process changes to existing GMP production processes.

We are looking for an Equipment engineer for general equipment (fridges, freezers, TSCU’s) and Upstream Processing (USP) LV Operations with who will strengthen our team of specialists with knowledge and expertise of TCSU’s, Cell culturing, Wave bioreactors, Single use Bioreactors, Shaker flask incubation and Cell counts.

As Equipment engineer you ensure that we meet the unmet needs of today by supporting the operations in making operational processes safer, easier, simpler and more stable. In this role you act as system owner, in which you are the first responsible person to perform acute troubleshooting and support of cGMP batches in the LV Operations. As system owners we enable operations to process first time right with our equipment and guidance. This varies from qualifications of the systems and processes, initial training, writing procedures and instructions till working together in project teams. We enable Operations to excel in production reliability through continuous innovation.

Besides this you will be playing a key role in the further development of the Business Unit in terms of new product introduction, efficiency, and reliability. The duties of the Equipment Engineer general and USP include:

• Manage and use the business processes, with which the equipment performance is analyzed and makes proposals for improvement points with the greatest impact on a specific objective (safety, quality, reliability/efficiency and costs).
• Identify, plan and control changes for system and process robustness (team task allocation and prioritization 0-3 months timeframe);
• Lead/owner business processes and projects that are mainly system or facility related, with peers in service oriented or operating departments.
• Ensures that the production equipment is in validated state, documentation is up to date, well maintained, and production capacity meets planning.
• Will play a key role in the interaction between our Operation Department on one site and the Maintenance and Engineering teams including the other sites.
• Generate the process equipment related reports and KPI’s. You will have the overview and knowledge of the status of the equipment (e.g. uptime, downtime, breakdowns, lifecycle management, occupancy rate and capacity).
• Initiate and execute test protocols that help to improve the system or process.

Qualifications/Requirements:

• Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
• Manufacturing specialist 3-4 years’ experience in a biotechnology or biopharmaceutical industry environment.
• Proven knowledge in the following aspects: Fridges / freezers (TCSU’s) Cell culturing, Incubators, Single Use Bioreactor control.
• Experience with cGMP environment and EHSS standards is required.
• Experience with Annex 1 guidelines is preferred.
• Able to perform trouble shooting 24/7 every 4 weeks.
• Positive attitude, proactivity, decisive, and organized with an ability to work individually and in a team.
• Excellent communication skills, written and verbal in English (B2 required) and Dutch (pre)

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Required Skills:

Preferred Skills:

Agile Manufacturing, Analytical Reasoning, Analytics Dashboards, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Data Analysis, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Manufacturing Standards, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Technical Credibility

The anticipated base pay range for this position is:

€44,700.00 - €70,840.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. (https://www.careers.jnj.com/en/life-at-jj/employee-benefits/)

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA