DPS

DPS is a leading Project Management and Engineering Company serving industry around the world for 40 years. Our reputation is based on forming successful partnerships with our clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
We provide Full Service Engineering for our clients including Project and Programme Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors. Our Main market sectors are; Pharmaceutical and Biotechnology, Medical Technologies, Oil & Gas, Advanced Technology, Science & Education, Food & Beverage, and Energy.

Job Description

As 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 analysed, deviations need to be investigation 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.

Responsibilities

As Process Engineer, you will be responsible for:

• 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).
• Conceptualiz405153.778945ing (process) improvements, define scope and deliverables, lead a team to implement agreed change and realiz405153.778945e 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 the work as well as personal skills. Note: In general, the Sr role will have ownership on more complex issues or priority projects.

Qualifications:

• Bachelor / Masters degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
• 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

Available and interested?

If you’re interested in this role and if you want to be part of growing organisation within engineering projects in the pharma industry or if you would like to discuss this vacancy further and to discuss your career options in confidence, please telephone Ralf Huisman on +31 6 11408791 or send your CV to ralf.huisman@dpsgroupglobal.com