QE Manager CSV – Lead GMP/CSV Validation for New Site

Bachem AG; Stein (AR); On-site; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Pension contributions 60%

Pension Plan Plus

Discount platforms

Staff restaurant

Free sports activities

Job summary

Bachem AG is seeking a Quality Engineering Manager CSV to lead quality oversight for computerized systems at the Sisslerfeld site. The role drives CSV, qualification and validation activities from design through commercial operations, ensuring regulatory compliance and inspection readiness.

Responsibilities include GMP compliance, reviewing qualification/validation docs, and providing QA oversight for commissioning, validation, and system releases with cross-functional stakeholders.

Qualifications

• University-level degree in Engineering, Chemistry or Pharmacy.
• Minimum of 3 years in pharmaceutical CAPEX projects involving CSV systems (PCS7/MES, MOS, LIMS).
• Thorough knowledge of regulatory requirements for qualification/validation of computerized systems and lab/process instruments.

Responsibilities

• Ensure GMP compliance across the project lifecycle.
• Review and approve qualification and validation docs (QMPs, URS, PSI, QRA).
• Provide quality oversight for commissioning/qualification of computerized systems (DQ/IQ/OQ/PQ).
• Support design, qualification readiness and compliance of systems (PCS7/MES, Monitoring, LIMS).
• Conduct design reviews and manage deviations, change controls, and releases from a quality perspective.
• Support supplier qualification and coordination with stakeholders for milestones.
• Ensure ongoing GMP compliance through quality oversight during operations.
• Support audits and regulatory inspections and drive QMS improvements.

Skills

CSV & C&Q

Regulatory compliance

Project management

Education

Engineering, Chemistry or Pharmacy degree

Tools

PCS7/MES

LIMS

MOS

KNEAT Gx

Job description

Bachem AG is seeking a Quality Engineering Manager CSV to lead quality oversight for computerized systems at the Sisslerfeld site. The role drives CSV, qualification and validation activities from design through commercial operations, ensuring regulatory compliance and inspection readiness.

Responsibilities include GMP compliance, reviewing qualification/validation docs, and providing QA oversight for commissioning, validation, and system releases with cross-functional stakeholders.