Greenfield CQV Engineer - GMP Validation Leader

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 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.