Senior Quality Systems & CSV Leader

Bachem Holding AG; Aargau; A distancia; CHF 140.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Internal development opportunities

Training opportunities

Pension fund contributions

Discount platforms

Staff restaurant

Sports activities

Descripción de la vacante

Bachem is hiring a QE Manager CSV for the Sisslerfeld site in Northwestern Switzerland. You will lead CSV, qualification and validation activities for computerized systems through design, implementation and operations, ensuring regulatory compliance and inspection readiness.

Join a pioneering team building a new GMP manufacturing site with strong cross-functional collaboration and a focus on quality and continuous improvement.

Formación

• 3+ years in pharmaceutical CAPEX projects with CSV systems (e.g., PCS7/MES, MOS, LIMS).
• Qualification and validation expertise for process systems used in API manufacturing.
• Thorough knowledge of regulatory requirements for qualification/validation of computerized systems, lab instruments and cleanroom utilities.

Responsabilidades

• Ensure GMP compliance and implement applicable regulations throughout project lifecycle.
• Review/approve qualification and validation docs (QMP, URS, SIA, QRA).
• Provide QC/CSV oversight for commissioning & qualification of computerized systems and IT equipment (DQ/IQ/OQ/PQ).
• Support audits and regulatory inspections; drive QMS effectiveness and continuous improvement.

Conocimientos

Quality systems oversight

CSV/QA expertise

GMP compliance

Regulatory compliance

Communication skills

English proficiency

Educación

Degree in Engineering/Chemistry/Pharmacy

Herramientas

PCS7/MES

LIMS

KNEAT Gx

Monitoring System

MOS

Descripción del empleo

Bachem is hiring a QE Manager CSV for the Sisslerfeld site in Northwestern Switzerland. You will lead CSV, qualification and validation activities for computerized systems through design, implementation and operations, ensuring regulatory compliance and inspection readiness.

Join a pioneering team building a new GMP manufacturing site with strong cross-functional collaboration and a focus on quality and continuous improvement.