Validation Engineer (Life Sciences)

agap2 Switzerland; Bern; On-site; CHF 90,000 - 130,000; Full time

Job summary

agap2 is a European engineering and operational consulting group seeking a on-site consultant for biotech/pharma validation projects in Switzerland. You will contribute to equipment integration, write specifications, and support commissioning activities in GMP environments.

Joining a long-standing Swiss client portfolio, you will perform IQ/OQ/PQ tests and participate in FAT/SAT activities, collaborating with the local team to ensure successful project delivery and client satisfaction.

Qualifications

• Experience in process validation and equipment qualification in a GMP environment.
• Understanding of biotechnology production processes (USP, DSP, F&F) essential.
• Fluent in German and English.

Responsibilities

• 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.

Skills

Process validation

Equipment qualification

GMP knowledge

Biotech production understanding

Fluent in German

Fluent in English

Education

Engineering degree in biotechnology

Process engineering

PharmD

Job description

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
• 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.