Yacht Life Sciences has a vacancy for a Manufacturing Process Specialist USP/ Equipment Engineer to work at Janssen Biologics in Leiden.
As a Manufacturing Process Specialist/ Equipment Engineer, you are responsible for the availability and functionality of the equipment required for the upstream production (USP) purposes. This includes:
- Work with cross functional team members, incorporating external manufacturing partners to ensure equipment meets varied quality, EHSS and compliance requirements
- Initiate and lead process and/or equipment improvement projects. This includes leading and executing Change Control processes, managing Business Improvements and defining User Requirements in consultation with a multidisciplinary team. Ensure that value-added improvements in the areas of capacity, safety (EHS&S) and quality (GMP) regarding equipment and/or process are implemented
- Participate in NPI projects and (global) multidisciplinary projects as an extended team member.
- Develop and sustain a long-term strategy for the asset such that manufacturing capacity remains adequate. Ensure that an Asset Team is in place to ensure life cycle management of the equipment.
- Actively lead and/or participates in investigations into deviations in production processes, identifies corrective and/or preventive actions and ensures that these are dealt with adequately and within agreed timelines.
- Provide first line support to manufacturing by, for example, providing expert advice to the shop floor in case of process issues.
- Take part of on-call duty for troubleshooting of process disturbances.
- Bachelor or Master education, in a relevant field (e.g. pharmaceutical sciences, biotechnology, biochemistry, life sciences, biological engineering, etc)
- > 3 years’ experience in a biotechnology or bio-pharmaceutical industry GMP environment
- Experience with upstream production processes and equipment
- Experience with upstream production equipment and automation systems (e.g. DeltaV)
- Experience working in a high quality environment (GMP)
- Experience with lean methodologies is a plus
- Excellent communication skills in English, additional Dutch is highly preferred
- Can work well both independently and in a team
- Good Data Analysis skills
- Good organizational change skills
- Good communication skills
- Flexible, “Can do!” mentality, critical and proactive
This concerns a direct contract at Janssen Biologics (J&J) for 1 year. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. They will offer a competitive benefits package in line with the seniority of the position (salary between 3200 and 5600 euro gross per month).
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
The Bioprocessing Department of Operations is responsible for the quality and safety of processes and the equipment used by the Fermentation, Pre-culture, Bioreactor Assembly, Primary Recovery, Downstream Processing and Column Packing departments. In addition, the department is responsible for investigating and immediately solving (technical and quality-related) deviations in the production process, including support in outside office hours as part of on-call duty. The department leads and participates in various projects to optimize and implement new equipment and processes.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.