Validation Engineer (Life Sciences)

agap2 Switzerland; Bern; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Strong development potential

Established in Switzerland with major,

Career development opportunities

Accredited training centers

Local management support

Dynamic, values-driven team

Zusammenfassung

agap2 is a European engineering and operational consulting group with a long-standing Swiss presence, seeking a consultant to support clients on site in biotech/pharma projects. The role emphasizes validation, testing, and commissioning within GMP environments.

The ideal candidate holds an engineering degree in biotechnology/pharma/process engineering (PharmD) and has hands-on experience in process validation, equipment qualification, and GMP practices, with fluent German and English.

Qualifikationen

• Engineering degree in biotechnology, pharmaceutical sciences, process engineering, or industrial pharmacist (PharmD).
• Experience in process validation and equipment qualification in a GMP environment.
• Understanding of biotechnology production processes (USP, DSP, F&F).
• Good Manufacturing Practices (GMP) compliance.

Aufgaben

• Contribute to integration of new production equipment and utilities in biotech/pharma environment.
• Create specifications (URS) and risk analyses (FMEA, FRA).
• Create and review the Validation Master Plan (VMP).
• Write and review test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ per GMP requirements.
• Participate in commissioning at suppliers (FAT).
• Participate in commissioning on customer site (SAT).
• Perform installation and operational tests (IQ/OQ/PQ).
• Work under supervision of a Lead Validator.

Kenntnisse

German language

English language

GMP knowledge

Ausbildung

Engineering degree in biotechnology/pharma/process engineering/PharmD

Jobbeschreibung

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.

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.

Tasks

• Contribution to the integration of new production equipment and utilities in a biotech/pharma environment
• Creation of specifications (URS) and risk analyses (FMEA, FRA)
• Creation and review of the Validation Master Plan (VMP)
• Participate in the creation and writing of test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ according to GMP requirements
• Participate in commissioning at suppliers (FAT)
• Participate in commissioning on customer site (SAT)
• Perform installation and operational tests (IQ/OQ/PQ)
• Work under the supervision of a Lead Validation

Requirements

• Engineering degree in biotechnology, pharmaceutical sciences, process engineering or industrial pharmacist (PharmD)
• Experience in process validation and equipment qualification in a GMP environment
• Understanding of biotechnology production processes (USP, DSP, F&F) essential
• Good Manufacturing Practices
• Fluent in German and English

Benefits

• 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 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 team 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.