Process Engineer

  • Den Bosch
  • 3500.00 - 5500.00
  • 32-40 uren
  • HBO

Opdrachtgever

Our client is a leading project management and engineering company for industry around the world.

Opdrachtgever

Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence. They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.

functie Vereisten

  • Academic degree in life sciences (Biotechnology or related) or comparable level through experience
  • Minimal 4 years’ experience as engineer at a (biologics) pharmaceutical manufacturer
  • Engineering knowledge of systems used in pharmaceutical industry
  • Engineering knowledge of pharmaceutical production/purification processes in USP and/or DSP.
  • Demonstrated track-record as lead process engineer in cross functional projects, leveraging both internal and/or external partners; supporting concurrent projects.
  • Knowledge of CGMP guidelines and regulatory expectations
  • Experienced in performing/reporting quality risk assessments (QRA) to support design and use of systems and on segregation of production/equipment flows.
  • Team player with ability to work in a multidisciplinary setting
  • Strong collaboration skills within an empowered (project) team setting
  • Must demonstrate personal commitment with respect to inclusion, working safely, healthy and environmentally friendly and all other guidelines.
  • Customer focused, process oriented and data driven
  • Experience with lean problem-solving methodologies for continuous improvement of e.g. costs, quality, process robustness, standardization)
  • Dutch (preferred) and English communication skills, verbally and written.

Wat krijg je?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Werkzaamheden

The role as Process Engineer is a critical technical role, ensuring systems used in the pharmaceutical production of biologics are in line with the GMP regulations. Specifically, he/ she will be responsible for supporting Upstream and Downstream manufacturing and providing expertise in (capital) projects on system design and execution, equipment user requirement specifications and process & facility fit assessments. The Process Engineer is does not have direct reports.

Primary responsibilities
  • Responsible for implementing the global guidelines and regulatory expectations in systems design (e.g. in URS, FDS, P&ID) and assure alignment with EHS requirements.
  • Experience in engineering/process calculations for e.g. sizing of equipment and facility fit assessments;
  • Creation of technical life cycle documentation required for qualification of equipment (e.g. IOPQ / pVMP)
  • Be point of contact regarding GMP process systems design (facilities/utilities/equipment)
  • Participate as SME in Quality Risk Assessments related to design and use of GMP systems (e.g. on segregation requirements of material and people flows).
  • Assess process, equipment, utility and/or facility changes for equipment qualification/validation impact.
  • Expected to bring equipment and process design expertise and strong analytical and systematic problem-solving skills, supporting investigation teams in the event of system failures to identify root cause and corrective/preventive actions. And where needed, support the IPTs for the Impact Assessment for equipment deviations.
  • Participate as SME during Pre-Approval Inspections, GMP inspections from Health Authorities and internal audits.
  • Persuasiveness based on expertise and science based arguments

TAGCLOUD

Bas Lokhorst

Geïnteresseerd?

Stuur uw cv naar bas@tailorminds.com onder vermelding van vacature id (1010)

Meer informatie?

Neem contact op met Bas Lokhorst van ons kantoor te Zoetermeer, te bereiken op nummer +31 6 82 43 66 08

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