Project Engineer Qualification

For our client, we are currently looking for an expert in the field of qualification for independent operational engineering activities or project work in the area of Drug Product.

The production facilities consist of the following machines and equipment:

• Filling machines (liquid/solids), encapsulation, tableting, granulation, labeling machines, inspection machines, assembly line for syringes & autoinjectors, equipment washing machines, autoclaves, etc.

• Infrastructure facilities: cold storage rooms, clean rooms, air conditioning/ventilation, compressed air, process air, WFI distribution, room monitoring, etc.

The ideal candidate will have completed vocational training or a university degree in a field such as automation, mechanical engineering, process engineering, pharmaceutical technology, or biotechnology. At least five years of professional experience in the qualification of automated pharmaceutical production facilities, as well as sound knowledge of GMP-regulated environments, are required. Further requirements include practical experience in implementing technical GMP requirements from regulatory authorities (Swiss medic, FDA, EMA) in investment projects and operational engineering.

A structured and meticulous work style, strong interpersonal skills, and the ability to communicate complex issues effectively to different target groups are essential for this position. Excellent German and English skills are mandatory.

Tasks & Responsibilities:

• Implementation and support of qualification activities in investment projects.
• Creating and executing qualification plans and reports
• Checking the supporting documents for GMP compliance and fulfillment of the acceptance criteria
• Create, track, and complete qualification tasks
• Maintaining the inventory data of qualified assets
• Collaborative partnerships with interfaces
• Presenting qualifications during inspections, answering inspection questions, maintaining the contact matrix.
• Assessing and evaluating the impact of changes and deviations on qualified status and critical aspects.
• Implementing (re-)qualification measures from changes and deviations
• Planning and conducting periodic qualification reviews
• Release of technical planning documents
• Take over inventory responsibility

Must Haves:

• Completed vocational training/studies in one of the following fields:
  Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Engineering, Biotechnology
• Minimum 5 years of professional experience in training for automated pharmaceutical production (Drug Product)
• Professional experience in a GMP-regulated work environment
• Strong social skills, teamwork skills and excellent communication and coordination skills, also in dealing with stakeholders at all levels
• Practical experience in implementing technical GMP requirements of regulatory authorities (Swiss medic, FDA, EMA) in investment projects and operational engineering
• Quick comprehension and the ability to break down complex issues and communicate them to customers or authorities in appropriate language.
• Excellent German and English skills are required.