Technical Manufacturing Specialist (DSP)

Location Leiden
Discipline: Biotechnology
Contact name: Isla Littlewood

Contact email: i.littlewood@panda-int.com
Job ref: 18898
Published: 29 days ago

Searching for an Experienced Technical Manufacturing Specialist – Vaccine bulk manufacturing downstream process for a top Biopharma client in Leiden!

Job Description:

As manufacturing specialist, you will be responsible for the assigned equipment to be available and robust to meet the production schedule. This includes direct support and leading the root cause analysis for operations whenever there is an issue, as well as improving the documentation, training and procedures related to the equipment. You will work closely with the manufacturing operators, GMP specialists, Maintenance department, Quality department, and process engineers.

 

Your responsibilites:

  • Acute troubleshoot & support production of cGMP batches. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.
  • In general, the associate role will merely have ownership on less complex systems and supports the manufacturing specialists in complex issues or priority projects.
  • Taking the lead in root cause investigations of low to medium complex deviations and for the implementation of preventive actions.
  • Initiating and handling of compliance records (change control, events, CAPA, deviations).
  • Initiate, and execution of test protocols that help to improve the system or process.
  • Working precisely, detecting and solving acute problems and communicate possible abnormalities.
  • As equipment owner, that the production equipment is in validated state, documentation and software recipes is up to date, well maintained, and capacity meets planning.
  • As equipment owner, 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.) 
  • Leading process excellence activities to continuously improve the work as well as personal skills.

Your profile:

  • Minimal bachelor degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
  • Minimal 4- years’ experience in similar job in a biotechnology or biopharmaceutical industry environment.
  • Experience in software recipe writing
  • Expert in downstream processing vaccine manufacturing (DSP).
  • Experience with cGMP environment and EHSS standards is required.
  • Certified Green Belt.
  • Good communication in English (Dutch is a plus)
  • Good communication and alignment on issue or change management.
  • Flexible in working acute troubleshooting with beeper from home (nights and weekends by circulation schedule).

Practicalities:

  • Location: Leiden - 60% on site/40% remote
  • 40 hours per week
  • Start date: ASAP
  • Contract: 1 year contract

For more info, please contact Isla Littlewood at +31 20 20 44 502 or i.littlewood@panda-int.com.