Quality Engineering Manager, CSV & GMP Lead

Bachem Holding AG; Stein; On-site; EUR 161,000 - 204,000; Full time

Benefits offered by this job

Career development

Pension benefits: 60%

Staff restaurant

Discount platform

Sports activities

Comprehensive training opportunities

Job summary

Bachem Holding AG is seeking a Quality Engineering Manager CSV to lead qualification and validation of computerized systems for our new Sisslerfeld site. You will drive CSV activities from design through operational phases, ensuring GMP compliance and inspection readiness.

Ideal candidates have 3+ years in pharma CSV within CAPEX projects, strong regulatory knowledge, and hands-on experience with PCS7/MES, LIMS and QA processes. English fluency is required; German is advantageous.

Qualifications

• University/Applied Sciences degree in Engineering, Chemistry, Pharmacy or related discipline.
• Min. 3 years in pharma CAPEX projects with CSV systems (PCS7/MES, MOS, LIMS).
• Qualification and validation for API process systems.
• Regulatory knowledge on qualification/validation of computerized systems, lab instruments, process systems, water systems, cleanrooms, cleaning and process validation.
• Experience with electronic validation systems like KNEAT Gx is a plus.
• Strong ownership, communication and organizational skills.
• English fluency; German a plus.

Responsibilities

• Ensure GMP compliance across the project lifecycle.
• Review and approve qualification and validation documentation (QMP, URS, SIA, QRA).
• Provide quality oversight for commissioning/qualification of computerized systems; validate PCS7/MES, LIMS, IT systems (DQ/IQ/OQ/PQ).
• Support design, qualification readiness, and regulatory compliance of computerized systems.
• Conduct design reviews; manage deviations, change controls, and system releases from a quality perspective.
• Support supplier qualification and cross-functional collaboration for milestone delivery.
• Maintain GMP compliance with quality oversight during operation and periodic reviews.
• Support audits and inspections; drive QMS effectiveness and continuous improvement.

Skills

CSV knowledge

C&Q experience

GMP compliance

Regulatory knowledge

Quality oversight

Communication skills

Project coordination

English proficiency

Education

Bachelor's degree in Engineering/Chemistry/Pharmacy

Tools

PCS7/MES

LIMS

KNEAT Gx

MOS

Job description

Bachem Holding AG is seeking a Quality Engineering Manager CSV to lead qualification and validation of computerized systems for our new Sisslerfeld site. You will drive CSV activities from design through operational phases, ensuring GMP compliance and inspection readiness.

Ideal candidates have 3+ years in pharma CSV within CAPEX projects, strong regulatory knowledge, and hands-on experience with PCS7/MES, LIMS and QA processes. English fluency is required; German is advantageous.