15 Mar, 2021

Senior Process Engineer

  • Johnson & Johnson
  • Leiden, Netherlands
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Job Description:

As Sr. Process Engineer, you will be responsible for an assigned process (or sub process).  For an existing process this means that on-going process data should be gathered and analyzed, deviations need to be investigated for potential product impact, changes should be evaluated prior to implementation and data gathered post implementation to prove that the change had the desired effect.

 

For new processes it means that the (small scale) developed process needs to be evaluated and the changes required within the VLF for the robust and compliant implementation of the process are defined precisely. The process engineer needs to work closely within the Technical Transfer team to ensure that the development knowledge is accurately transferred into the operational documentation.

 

In both situations you will work closely with the manufacturing specialists (system owners), operators, GMP specialists, Quality department and the process development group (VPAD).

 

The process engineer must be a Subject Matter Expert (SME) and needs to be up to speed with all developments internally as externally on the process.

 

 As Process Engineer, you will be responsible for: 

 

Participates in comprehensive engineering activities to develop and implement effective, high quality processes using industry standard design methods to reduce production risk and increase manufacturability.

 

Executes moderately complex design reviews and supplies feedback for improvements in manufacturability.

 

Assesses equipment, material, and process performance to achieve the overall process yield goals. Performs vendor searches and equipment evaluation to ensure adequate capability to produce quality products in required quantities at an effective cost.

 

Facilitates experiments and capability studies, develops process specifications, and supports design of process equipment.

 

Evaluates and advises on the selection of suitable equipment for optimized process performance.

 

Analysis of (new) systems and equipment with the intent of improving yield, process times and/or change over times.

 

Edits and publishes process documentation and training materials for processes, materials, and equipment.

Ensuring that the implemented process is well defined and aligned with the operational procedures.

Supporting production of cGMP batches in the VLF. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.

Taking the lead in root cause investigations of complex deviations where there is (potentially) significant product impact and for the implementation of preventive actions.

Initiating and handling of compliance records (change control, events, CAPA, deviations).

Conceptualizing (process) improvements, define scope and deliverables, lead a team to implement agreed change and realize the agreed goal.

Having the overview and knowledge of the status of the process (e.g. stability of critical parameters, ongoing investigations, registered process)

Identifying and participating in improvement projects to increase the speed, reliability, yield or capacity of the process.

Leading process excellence activities to continuously improve work-flows.

Note: Experience will determine the complexity of assigned issues and/or projects


Qualifications

 

  • Bachelor / Masters degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
  • Jnr Process Engineer 0-2 years’ experience in a biotechnology or biopharmaceutical industry environment.
  • Process Engineer 2-4 years’ experience in a biotechnology or biopharmaceutical industry environment. 1-2 years for WO graduate
  • Snr Process Engineer 4-8 years’ experience in a biotechnology or biopharmaceutical industry environment. 2-4 years for WO graduate
  • Experience with cGMP environment and EHSS standards is required.
  • Certified (Lean) Green Belt.

 

 

 

 Competences:

  • High degree of accuracy, initiative, and independence.
  • Innovative and exploring person which detect abnormalities.
  • Flexible, can deal with changing priorities and stress-resistant.
  • Enthusiastic team player.
  • “Can do” attitude, critical and proactive.
  • Practical technical understanding and conceptual thinking.
  • Good communication in Dutch and English, both verbally and in writing.
  • Good communication and alignment on issue or change management
  • Critical analysis of production issues
  • Clear and Concrete Communication
  • Self-awareness
  • Influencing and Negotiating
  • Applied Judgment
  • Adaptability

 

Specific Knowledge / Skill set:

  • Project management.
  • Pharmaceutical and/or bio processing principles typically used in Upstream and Downstream processing for vaccines manufacturing using disposable technologies (e.g. bioreactors & filtration systems)
  • Design experience and working knowledge of automatic bulk filling systems for pharmaceutical material in Grade A environments and/or closed filling systems.
  • Understanding of liquid freezing processes and its potential impact on vaccine storage and stability.
  • Understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and maintenance & engineering (e.g. GMP, NEN3140, VCA, CE, etc.)

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