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Manufacturing Process Engineer

Agap2 - HIQ Consulting AG
Bel-Air 1, 1003 Lausanne
4T
  • 07.04.2024
  • 100%
  • Mitarbeiter
  • Festanstellung

Agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Life Science, Energy, Infrastructure, Transportation, Chemicals sectors.

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio

Manufacturing Process Engineer

Main duties & responsibilities:

The purpose of this role is to manage deviations occurring in our clients' various manufacturing units (USP and DSP), for the different products within quality system (i.e. Trackwise) in a timely manner:

  • Perform evaluations related to impact on concerned equipment/product/material with the support of relevant experts.
  • Perform root cause investigations using Six Sigma methodologies, including ability to collect and analyze data in the different automated systems and on-the-floor (regular GEMBA).
  • Identify and implement relevant corrective and preventive actions (CAPA), including business case and planning preparation with relevant stakeholders.
  • Write investigation and impact assessment reports in a comprehensive and scientific format
  • Present report-out and/or escalate blocking points to line Manager
  • Monitor and control internal deviations and CAPA KPI in concertation with line Manager
  • Depending on deviation complexity, lead cross-functional investigation team including workshop or brainstorming sessions

Required skills :

  • Bachelor/Master in Engineering field (chemical, biotechnology) or equivalent experience
  • 3-5 years of experience within a biotech/pharmaceutical GMP manufacturing environment (manufacturing, quality or support functions
  • Strong knowledge and interest in biotechnological processes (USP and/or DSP)
  • Good knowledge of cGMP and associated regulations
  • USP background would be a plus instead of DSP (it is nice to have, not a must).
  • Fluency French and excellent command of English (fluency is an asset).

Thank you for your interest in this opportunity. Please note that only candidates selected for a first exchange will be contacted.

Place Bel-Air 1 1003 Lausanne