CQV Engineer

agap2 Switzerland; Basel; On-site; CHF 140,000 - 190,000; Full time

Job summary

agap2 Switzerland is seeking a consultant to support large-scale biotech/pharma projects on-site in Basel. You will help define, qualify, and launch state-of-the-art production lines within a brand-new greenfield facility, under GMP/MDR requirements.

The role focuses on validating systems, writing URS, performing risk analyses, and leading VMP development with close collaboration across engineering, suppliers, and operations to achieve GMP-compliant startup.

Qualifications

• Degree in biotechnology, pharmaceutical sciences, process engineering, or PharmD with an industrial focus.
• Solid experience in GMP process validation and equipment qualification.
• Strong command of Good Manufacturing Practices.

Responsibilities

• Define technical expectations by developing high-impact URS and performing comprehensive risk analyses (FMEA, FRA).
• Lead the creation and review of the Validation Master Plan (VMP) for newly installed equipment, utilities, and production areas
• Design, write, and optimize qualification and commissioning protocols (FAT/SAT/IQ/OQ/PQ) for new production lines, new packaging lines, and new utilities under strict GMP/MDR requirements
• Actively participate in FAT/SAT at supplier sites and on-site to ensure flawless equipment delivery and readiness
• Execute and document IQ/OQ/PQ activities to qualify all new systems and guarantee GMP-compliant startup
• Collaborate closely with engineering, suppliers, and operations to bring an entire greenfield site to operational excellence

Skills

GMP

Process validation

Equipment qualification

URS development

FMEA

FRA

IQ/OQ/PQ

GMP/MDR compliance

Education

Biotechnology, pharmaceutical sciences, process engineering, or PharmD (industrial focus)

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.

Your Mission

Become a key player in a brand-new greenfield project where you will help build, qualify, and launch state-of-the-art production and packaging lines from the ground up. This is your chance to shape an entire facility’s future in a high-growth biotech/pharma/medtech environment.

You will take part in every critical stage of bringing new systems to life:

• Define technical expectations by developing high-impact URS and performing comprehensive risk analyses (FMEA, FRA)
• Lead the creation and review of the Validation Master Plan (VMP) for newly installed equipment, utilities, and production areas
• Design, write, and optimize qualification and commissioning protocols (FAT/SAT/IQ/OQ/PQ) for new production lines, new packaging lines, and new utilities under strict GMP/MDR requirements
• Actively participate in FAT/SAT at supplier sites and on-site to ensure flawless equipment delivery and readiness
• Execute and document IQ/OQ/PQ activities to qualify all new systems and guarantee GMP-compliant startup
• Collaborate closely with engineering, suppliers, and operations to bring an entire greenfield site to operational excellence

Your Profile

You are motivated by large-scale challenges and the opportunity to design, qualify, and launch systems in a completely new facility.

You bring:

• A degree in biotechnology, pharmaceutical sciences, process engineering, or a PharmD with an industrial focus
• Solid experience in GMP process validation and equipment qualification
• A strong command of Good Manufacturing Practices