NL - Process Equipment Engineer

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

Would you like to be the person that is helping us realizing novel vaccines for the world? Continue reading, we would like to get in contact!

Janssen Vaccines & Prevention is one of the Janssen Pharmaceutical Companies of Johnson & Johnson and is passionate about the development, production, and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where we proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV, and Ebola. This is also the place where were producing the batches of COVID-19 vaccine material.

To strengthen the Operations Support Team within DSO we are looking for a Process Equipment Engineer, to help us with the upcoming manufacturing campaigns for our vaccines.

Department:

The department DSO is an international team of about 40 people working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to support the development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA, and warehouse. Our passion is to deliver high-quality results to our customers and to seek opportunities for improvement: never a dull moment!

Within the department four teams operate, each with specific responsibilities: Preparations, Cell culture, Downstream processing, and the Operations Support Team. The teams are responsible for their cGMP status by regular equipment care, maintaining the documentation system, reporting quality issues, and performing the resulting corrective actions, training, and inspection readiness.

Job description:

The Process Equipment Engineer is the first point of contact within Engineering, Validation, and Maintenance (EVM) to introduce new equipment and maintain the existing equipment. Together with the development teams and EVM, processes (in sync with cGMP regulations) are introduced in the pilot facility including documentation and training. The ultimate task is to assure equipment is available at all times, to allow smooth operation activities.

As a Process Equipment Engineer you will:

• be the first departmental contact for questions about equipment
• lead to assure the availability of compliant equipment and processes in the department
• be expert about equipment data integrity topics in a cGMP environment
• support troubleshooting and investigation in non-conformances (process and equipment related)
• lead and support process excellence activities to continuously improve the work
• initiate and handle equipment related compliance records (change controls, non-conformances and CAPA records)
• work precisely and detect opportunities for improvement with proper follow up, both on work processes as well as personal development
• designs comprehensive engineering activities to develop and implement effective, high quality processes and design guidelines for dissemination through out the division
• provide complex design reviews and feedback for improvements in manufacturability
• develops equipment, materials, and process performance requirements, performs vendor searches and equipment evaluation to ensure adequate capability to produce quality products in required quantities at effective costs
• designs experiments and capability studies, develops process specifications, and designs and procures process tooling
• analyze new processes and equipment with the intent of achieving continuous improvement of present methods
• communicate and monitor process and material quality targets
• measure performances to targets and implements remedial actions as instructed
• develop process documentation and training materials for new processes, materials, and equipment

Qualifications:

• HBO with 4-6 years’ experience in the pharmaceutical industry/biotechnology (cell culture equipment, downstream process equipment, etc.)
• Experience with cGMP and EHSS standards is required. Proven experience with handling change controls, deviations, etc.
• Lean green belt certification is preferred
• Project leadership skills
• Quality Assurance understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and maintenance and engineering (e.g. GMP, NEN 3140, VCA, CE)

The candidate...

• has a high degree of accuracy, initiative, and independence
• has eye for bigger picture
• is flexible and stress-resistant and remains positive when priorities change
• helps team members by giving advice and sharing feedback
• communicates clearly in English, both verbally and in writing
• has affinity with computerized systems and equipment data flows.
• is proactive, self-starter, curiosity and eye for improvement.

EXTRA INFORMATION:

• This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner YACHT. They can offer you a contract for the duration of the assignment at J&J, a one year contract or a freelance contract (ZZP).