- Localisation : Basel, Basel-City Switzerland
- Poste : Aseptic Fill & Finish Process Engineer (m/f/d)
- Sector: Life Science
- Type de contrat : Permanent
- Date de démarrage : ASAP
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.
Vos missions principales sont :
Design & engineer aseptic fill & finish processes
- Define and develop process concepts and URS for aseptic filling lines (isolator/RABS, filling machines, lyophilizers, capping, stoppering)
- Contribute to the design of equipment, process flows, material and personnel flows, and the contamination control strategy (CCS)
- Review vendor documentation (FDS, P&IDs, layouts) and take part in FAT/SAT
- Provide process expertise in cross-functional design reviews with engineering, automation, quality and operations
Qualify & validate with a risk-based approach
- Prepare, execute and approve qualification documentation (DQ, IQ, OQ, PQ) for filling lines and associated equipment
- Lead process validation activities, including Media Fills (APS), sterilization/decontamination cycles (VHP, steam, depyrogenation) and container closure integrity
- Define and validate visual inspection processes (manual, semi-automated and automated), including AQL, defect libraries, kit qualification and operator qualification
- Ensure compliance with EU GMP Annex 1, FDA guidelines, ASTM E2500 and GAMP 5
Support operations & continuous improvement
- Support start-up, technology transfer and scale-up of new aseptic fill & finish lines
- Handle deviations, CAPAs and change controls, and run root cause investigations
- Contribute to process improvement and optimization of yield, line efficiency and robustness
- Prepare for and support regulatory inspections and customer audits
Keep the project on track
- Report on key deliverables and milestones in line with the project’s critical path
- Contribute to risk assessments (FMEA, HACCP) and evaluate the effectiveness of mitigation measures
- Coordinate with vendors, internal teams and quality stakeholders on site
Ce poste est fait pour vous si...
- A Bachelor’s or Master’s degree in Life Sciences, Process or Pharmaceutical Engineering, or a related field
- At least 5 years of experience in aseptic fill & finish in a pharmaceutical or biotech environment
- Solid knowledge of isolator/RABS technologies, filling equipment, lyophilization, and sterilization and decontamination methods
- Hands-on experience in design, process development, qualification (DQ/IQ/OQ/PQ) and validation, ideally including Media Fill
- Knowledge of visual inspection (manual, semi-automated and automated) is a clear advantage
- Strong knowledge of cGMP, EU GMP Annex 1, FDA requirements and risk-based approaches (ASTM E2500, GAMP 5, ICH Q9)
- Independent, structured and solution-oriented working style with excellent communication skills
- Fluent English and German
Nous rejoindre, c’est...
- 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.