Project Engineer Commissioning & Qualification
Autostream Global are supporting multiple life science companies. This global leader is looking for a Project Engineer that specialises in commissioning and qualification, that can be placed across multiple sites in the Netherlands.
- Coordinate and organise external parties for commissioning & qualification.
- Operate as an independent team member or department representative in multidisciplinary projects.
- Assessing change controls and making validation assessments.
- Determining the validation strategy, drawing up validation plans, protocols, and reports, and conducting the internal review of protocols and reports.
- Training and guiding colleagues for validation activities.
- Providing support for deviations.
- Periodically checking and updating the processes, procedures, protocols, and standards for commissioning & qualification and improving them where possible.
- Realising the transition from the currently used V-model to the risk-based method according to ISPE volume 5, Commissioning & Qualification second edition
- Coordinate the workload of the team with the demand (at least 3 months in advance) and initiate the influx of new Change controls / qualification requests within the team
- Presiding weekly team meeting
- Daily coordination of activities and questions for the Qualification team.
- Acting as commissioning & qualification expert from Engineering during internal and external audits and inspections.
- Maintaining contacts with colleagues from other sites.
- HBO education.
- At least 3 years of relevant work experience in the (bio) pharmaceutical industry.
- Good exposure to Microsoft Office suite (Word, Excel, PowerPoint, Outlook, SharePoint, etc.)
- Familiar with cGMP, ICH, FDA and EMA Guidelines and Standards.
- Experience with cGMP inspections, process excellence and project management are a plus.
- Team player who can also function as a coordinator and coach colleagues
- Accurate, structured, flexible and customer oriented.
- Good communication skills in the Dutch and English language (both oral and written).