Downstream QE Manager - GMP & Validation Lead

Bachem; Stein; On-site; CHF 150,000 - 190,000; Full time

Benefits offered by this job

Pension plan

Staff restaurant

Sports facilities

Discount platforms

Job summary

Bachem Group is building a new Sisslerfeld site in Northwestern Switzerland. As QE Manager Downstream you will provide Quality oversight across cross-functional teams to deliver compliant, robust, and inspection-ready manufacturing systems from startup through commercial operations.

Your tasks include GMP compliance, approving qualification and validation documentation, overseeing C&Q and CSV activities, and ensuring equipment and facilities meet regulatory requirements.

Qualifications

• University degree in Engineering, Chemistry, or Pharmacy.
• Strong knowledge of C&Q and CSV with pharma CAPEX downstream experience.
• Experience with qualification/validation of process systems and software.

Responsibilities

• Ensure GMP compliance and regulatory alignment throughout the project lifecycle.
• Review and approve qualification, validation, and risk management docs.
• Provide Quality Engineering oversight for C&Q and CSV activities.
• Support design, qualification readiness, and compliance of manufacturing systems.
• Conduct design reviews and manage deviations, change controls, and releases.
• Oversee calibration and maintenance of equipment, facilities, and systems.
• Maintain GMP oversight during operations and support audits/inspections.

Skills

Quality Engineering

C&Q knowledge

CSV knowledge

Regulatory compliance

Project experience

Communication skills

Organizational skills

Problem-solving

Education

University degree in Engineering, Chemistry, Pharmacy

Tools

KNEAT Gx

Job description

Bachem Group is building a new Sisslerfeld site in Northwestern Switzerland. As QE Manager Downstream you will provide Quality oversight across cross-functional teams to deliver compliant, robust, and inspection-ready manufacturing systems from startup through commercial operations.

Your tasks include GMP compliance, approving qualification and validation documentation, overseeing C&Q and CSV activities, and ensuring equipment and facilities meet regulatory requirements.