Challenge The Future With Us – Join Our Global Team

At H&T Presspart we co-develop, produce and supply drug delivery technologies to prolong patient lives by focusing on unmet needs of patients, users and customers. As a family-owned H&T group we employ ca. 2000 people in 9 countries, we focus on long-term performance and we believe in talented and ambitious people who are passionate about serving the pharmaceutical industry. Visit www.presspart.com to learn more about us.

Quality Project Engineer

Apply for the position of Quality Project Engineer (external link)

As Project Quality Engineer, you will represent quality into projects for new product development, product introduction, product maintenance and capacity expansions (new laboratory equipment, machinery and moulds). You will be responsible for the execution of all quality assurance in projects until project handover.

  • Main contact with customers regarding quality issues throughout the project’s lifecycle.
  • Ensure the project is executed according to internal and external relevant standards / procedures and act as the quality referent for the project team.
  • Participate actively to definition and review of qualification and validation protocols – CSV, Product, Process, Systems – ensure data driven validations and qualifications, process capability studies and monitor progress.
  • Oversee, alert if required and actively participate to investigation according to Presspart principles for all deviations related to product and process qualifications and to product compliance.
  • Where required, participate actively to definition of robust containment actions and CAPA definition to close gaps and secure launch
  • Specify, monitor manufacturing and approve gauges, checking and measurement equipment.

Your Key Responsibilities

  • Plan, define, supervise and improve all relevant Measurement System Analysis for visual inspections, functional tests and measurements.
  • Develop the product control plan and test methods definition in collaboration with customer and project team.
  • Lead management of product quality attributes according to Presspart quality/customer standards.
  • Ensure proper Quality documents are established: Actively participate to definition and review of product specification, defect catalogue, test methods, SOPs and instructions with cross functional team support.
  • Ensure proper transfer of products/ processes to the operational team.
  • Participate actively in Design and Process FMEAs while maintaining consistency from functional analysis based on product URS, through risk assessment, up to completion of process and product qualifications.
  • Lead quality improvement projects: establish planning, budget and manage the project team as well as project reporting.
  • Represent quality during audits on projects he / she was involved in

Your Key Capabilities

  • Master’s degree or diploma degree with major focus in an engineering / science related discipline
  • Minimum 3 years of experience in production or in engineering center – industries targeted biotech, pharma, API/Excipients manufacturing (desirable).
  • Strong GMP, Medical device & industry standards knowledge, i.e. 21 CFRs, ISO13485
  • Strong basics in statistics, i.e. normal distribution, process capabilities, MSA and SPC
  • Strong problem solving methodologies knowledge, i.e. 8D,
  • Experience in international working environment
  • Strong communication skills in English (advanced both written and spoken)
  • Validation and project management experience

What we offer

  • Open and highly collaborative culture: mutual support within teams and working as equals, team spirit and international collaboration
  • High degree of self-responsibility and independent working
  • Attractive working conditions and performance-related remuneration

All qualified applicants will be considered for employment without regard to race, color, religion, sex or national origin.

Apply for the position of Quality Project Engineer (external link)