Sr Equipment Engineer Fill & Finish

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Senior equipment engineer Fill Finish CoE LVV facility BU5

Location: Leiden Site Sassenheim Nederland

Department: LVV FACILITY BU5 Centre of Expertise (CoE)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions 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 the Role

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

The CoE is a critical team in the direct support of Operations when it comes to technical process and reliability of equipment. 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 LVV manufacturing. CoE is responsible for supporting the production teams with specialized and in-depth knowledge and skills in our production processes GMP (Annex1) 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 4 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). Supported by a separate team with GMP specialists 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 a Senior equipment engineer Fill & Finish who will strengthen our team of specialists with knowledge and expertise of the filling labeling and visual examination process and equipment according to Annex 1.

Responsibilities that YOU have:

As Senior equipment engineer Fill & Finish you ensure that we meet the unmet needs of today by supporting the operations in making operational processes safer easier simpler and more 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 LVV facility. As system owners we enable operations to process first time right with our equipment and guidance. This varies from initial training writing procedures and instructions till working together in project teams. We enable Operations to excel in production reliability. This includes process documentation initial training of operations and qualifications of the systems and processes.

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 Senior equipment engineer Fill & Finish 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).

• Perform acute troubleshooting & support production of cGMP batches in the LVV.

• Identify plan and control changes for system and process robustness (team task allocation and prioritization 0-12 months timeframe);

• Lead/owner business processes and projects that are mainly system or facility related with peers in service oriented or operating departments.

• Guaranties 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 on the other site.

• Generate the process equipment related reports and KPIs. 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.

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

• Bachelors degree in biotechnology biochemistry biomedicine process technology (or equivalent education).

• Manufacturing specialist 4-6 years experience in a biotechnology or biopharmaceutical industry environment.

• Proven knowledge in at least one of the following aspects: Annex 1 Drug Product Filling Visual Inspection DS Labelling

• Experience with cGMP environment and EHSS standards is required.

• 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)
  

The anticipated base pay range for this position is 53500.00 to 96500.00 EUR on an annual basis and includes 8% holiday allowance

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