Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

As a Senior Engineer CSV based in Lengnau, you will have the outstanding opportunity to develop the future of our Automation department. You will ensure our processes meet the highest standards of cGMP compliance. Your work will be highly impactful as you help maintain our reputation for flawless execution and world-class quality.

Responsibilities

• Assist in the deployment and oversight of quality systems and processes to ensure cGMP adherence within the Automation department.
• Ensure consistency and a unified approach to systems validation within the Automation Systems department.
• Assist the Manufacturing Engineering management team with CSV activities, including planning, forecasting, and resource management to successfully implement projects within timelines.
• Maintain validation of "cGMP" Execution Systems, ensuring they are always in an "inspection ready" state. Relevant systems include PCS, MES, ELS, CDA, EMS, Access Management System, Data Historian, and COMOS DMS.
• Act as a delegate for internal and external inspections/audits related to CSV.
• Assist in managing deviations within the Automation department.
• Track GMP trends to ensure CSV practices are implemented.
• Define validation strategies tailored to computerized systems.
• Collaborate closely with peers in the Automation department, Information Technology, Quality Management, Drug Substance Manufacturing, and Engineering & Facilities.

As the DI Single Point of Contact (SPOC):

• Act as liaisons between departmental teams and the DI officer.
• Ensure regular DI Surveillance through Gemba Walks, internal DI moments, huddles, and trainings.

Join us at Thermo Fisher Scientific and contribute to our ambitious goals by applying your proven expertise in CSV!