On-Site GMP Validation Engineer - Biotech/Pharma

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 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.