Information
- Location: Berne, Suisse
- Position: Process Validation Engineer (Pharma/Biotech)
- Sector: Life Science
- Type of contract: Permanent contract
- Starting date: ASAP
agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology 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.
Your main missions are:
- Intervention on process validation projects in biotechnology/pharma production
- Preparation of the validation :
- Drafting of risk analyses to determine the critical parameters (CPP) and acceptance criteria (AQC) of the process.
- Definition of the validation strategy: validation perimeter, cleaning process, controls to be performed, analysis methods, recording and evaluation of results, sampling plan, validation test schedule
- Drafting or follow-up of validation documents:
- Ensure prerequisites (qualification of IQ, OQ, PQ equipment, process validation)
- Writing of validation protocols (validity criteria, compliance and retention time)
- Planning of associated tests
- Supervision of the execution of the tests
- Training of operators or test performers to the different qualification documents
- Assistance and verification of the test forms and proofs produced, follow-up of the processing of anomaly forms, re-execution of the tests if necessary
- Elaboration of KPI’s and reporting to the project manager
- Writing of the final validation report
This job is made for you if...
You have…
- An Engineering degree in biotechnology, pharmaceutical sciences, process engineering or industrial pharmacist (PharmD)
- Experience in process validation and equipment qualification in a GMP environment
- An understanding of biotechnology production processes (USP, DSP, F&F) essential
- Proven experience in GMP (Good Manufacturing Practices)
- Fluency in English (German is highly beneficial)
Working with us means...
- Joining a group with strong development potential that aims to improve your employability on challenging and varied projects
- Joining a structure that has been established in Switzerland for a long time with a client portfolio that includes the leaders in the sector
- Having a sustainable job with stability and access to a real collaboration
- Benefit from training with accredited and certified centers
- Having a local management to support you in the achievement of your missions and in the development of your career
- Being part of a dynamic, committed team with real human values that we live by every day
Only applications from Swiss and EU citizens will be considered. Please note that due to Brexit we are no longer accepting applications from the UK.