Validation Engineer (Life Sciences)

agap2 Switzerland; Bern; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Career development

Stable position

Training programs

Local management support

Collaborative team

Strong portfolio

Zusammenfassung

agap2 is a European engineering and operational consulting group specializing in biotech, pharma, and life sciences, with a strong Swiss presence.

As a consultant, you will support client projects on site, applying your expertise in process validation, equipment qualification, and GMP compliance.

Fluent German and English are required; the role offers varied projects, on-site deployments, and ongoing professional development.

Qualifikationen

• Engineering degree in biotechnology or related field.
• Experience with process validation and equipment qualification in GMP.
• Understanding of biotech production processes (USP, DSP, F&F) is essential.
• Good Manufacturing Practices knowledge.
• Fluent in German and English.

Aufgaben

• Contribute to integration of new production equipment and utilities in biotech/pharma settings.
• Create specifications (URS) and perform risk analyses (FMEA, FRA).
• Develop and review Validation Master Plans (VMP).
• Create/write test protocols for commissioning and qualification (FAT/SAT/IQ/OQ/PQ) per GMP.
• Participate in commissioning at suppliers (FAT) and at customer sites (SAT).
• Perform installation and operational tests (IQ/OQ/PQ) under supervision.

Kenntnisse

Process validation

Equipment qualification

GMP knowledge

German language

English language

Ausbildung

Engineering degree in biotechnology, pharmaceutical sciences, process engineering or industrial pharmacist (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.

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.