Senior Materials & Cleaning Validation Lead

MSD Merck Sharp & Dohme AG; Luzern; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

MSD Merck Sharp & Dohme AG, Schachen Biotech site in Lucerne, is seeking a Materials and Cleaning Validation Senior Specialist to lead cleaning validation and Single Use Technology activities, ensuring compliance with internal standards and regulatory requirements while supporting new products and processes.

You will collaborate with Technology, Engineering, Operations and Quality to develop documentation, train staff, and prepare for audits, contributing to robust, reliable manufacturing

Qualifikationen

• Bachelor's degree in biology, chemical engineering, or related discipline with 6+ years, or MS with 4+ years in GMP pharma/biotech.
• Minimum 3 years of experience in cleaning validation within GMP environment.
• Strong understanding of cleaning chemistry, residue limits, analytical methods, and equipment design.
• Knowledge of FDA, EMA, PIC/S, ISPE guidance.
• Excellent analytical and detail-oriented skills.
• Working knowledge of cGMP regulations.
• Demonstrated supervisory and leadership skills.
• Excellent oral/written English (C1).

Aufgaben

• Lead the site cleaning validation program and develop, update, and execute cleaning validation documentation (protocols, reports, studies, risk assessments).
• Design and improve cleaning procedures for new products, equipment, and processes, including clean-in-place practices.
• Support timely introduction of NPI and new equipment into the validation program through technical assessment, planning, and execution.
• Review and approve cleaning-related working instructions, forms, and change controls.
• Investigate cleaning-related incidents, deviations, and OOS results with root cause analysis and troubleshooting.
• Support periodic review of cleaning validation studies and closure of incidents and deviations.
• Train manufacturing, QC, and QA personnel on cleaning validation documentation and compliance.
• Prepare for and support audits and inspections related to cleaning validation.
• Contribute to the development and execution of the Single Use Technology strategy across Technology, Operations and Quality.
• Develop and maintain SUT flow diagrams, process closure requirements, and design standards.
• Standardize materials of construction, sizes, and connectors to reduce complexity.
• Support facility design reviews, vendor collaboration, and component-level specifications/drawings.
• Maintain the SUT database and manage design changes through the project lifecycle.
• Facilitate stakeholder workshops to define process requirements and approve SUT specs.
• Identify SUT requirements to support commissioning, qualification, verification, procurement, and schedule adherence.
• Support SUT change management, root cause investigations, and CAPA closure.
• Coordinate Extractable & Leachable assessments and ensure vendor data is reviewed on timeline.
• Review and approve SUT risk assessments, calculations, and reports.

Kenntnisse

Analytical skills

Detail oriented

cGMP knowledge

Supervisory/leadership

English communication (C1)

Ausbildung

Bachelor’s degree in biology/chemical engineering or related

Master’s degree in biology/chemical engineering or related

Jobbeschreibung

MSD Merck Sharp & Dohme AG, Schachen Biotech site in Lucerne, is seeking a Materials and Cleaning Validation Senior Specialist to lead cleaning validation and Single Use Technology activities, ensuring compliance with internal standards and regulatory requirements while supporting new products and processes.

You will collaborate with Technology, Engineering, Operations and Quality to develop documentation, train staff, and prepare for audits, contributing to robust, reliable manufacturing