Cleaning Validation Expert (m/f/d)

Senior Cleaning Validation Expert role at Merck (Schweiz) AG in Aubonne, CH, focusing on biotechnological cleaning process validation for Drug Substance and Product within the MSAT team.

This position belongs to the Cleaning Validation group inside the Manufacturing Sciences and Technologies (MSAT) department. The primary objective involves validating cleaning procedures for biotechnological processes related to both Drug Substance and Drug Product.

Responsibilities

• Establish validation approaches for new product launches, technology transfers, cleaning process validations, or modifications impacting commercial items.
• Assess risks, identify optimization opportunities, select technical solutions, and address operational limitations.
• Design cleaning procedures when necessary to facilitate effective validation execution.
• Liaise with relevant departments to coordinate on-site cleaning validation activities.
• Generate essential documentation, including plans, protocols, reports, and risk assessments, within deadlines.
• Instruct manufacturing staff on validation protocols.
• Oversee and assist with protocol implementation, potentially requiring work outside regular hours.
• Maintain accurate records and manage data through appropriate information systems, including quality management platforms.
• Gather and compile data from production activities.
• Analyze outcomes from cleaning process validation trials.
• Handle deviations and validation investigations within the designated system.
• Oversee cleaning process monitoring, including form creation, scheduling, execution, and reporting.
• Update and refine validation procedures and standards.
• Contribute to a culture of integrity and professional ethics.
• Ensure adherence to legal, regulatory, and company directives.

Requirements

• Master of Science in Biotechnology, Life Sciences, (Bio)Chemistry, or equivalent, or minimum 5 years of professional experience in biotechnology.
• Proven experience in Cleaning validation.
• Strong analytical and synthesis capabilities.
• Excellent writing skills.
• Proficiency with GMP/GDP and good knowledge of health authority requirements.
• Organized, persistent, and resilient.
• Collaborative mindset and ability to work well in a team, plus the ability to work independently and autonomously.
• Very good communication skills.
• Aptitude for digital tools.
• Fluent in French and English (spoken and written).

What the company offers

• We are committed to creating access and opportunities for all to develop and grow at your own pace.
• Join us in building a culture of inclusion and belonging.

About the company

Merck (Schweiz) AG operates in the healthcare sector with a mission to help create, improve and prolong lives. The company develops medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. The company fosters a diverse, inclusive and flexible working culture. The company values curiosity and innovation in science and technology. The company believes variety in backgrounds and perspectives drives excellence and innovation.

• The company's purpose in Healthcare is to help create, improve and prolong lives.
• The company develops medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.
• The company fosters a diverse, inclusive and flexible working culture.
• The company values curiosity and innovation in science and technology.
• The company believes variety in backgrounds and perspectives drives excellence and innovation.