About Inova :

Inova is a premier pharmaceutical consulting firm based in Switzerland, known for delivering cutting-edge solutions in the pharma industry. Our team of experts specializes in guiding pharma companies through complex regulatory landscapes and ensuring the highest standards of product quality and safety.

Job Overview:

We are seeking a motivated and experienced CSV Engineer to join our dynamic team in Switzerland. In this role, you will play a crucial part in ensuring the compliance and efficiency of our computerized systems within a cutting-edge and innovative context. As a CSV Engineer, you will be responsible for validating and maintaining the integrity of critical software systems, ensuring they meet regulatory requirements and industry standards.

Key Responsibilities:

• Develop and execute validation protocols and documentation for computerized systems, including but not limited to laboratory information management systems (LIMS), electronic document management systems (EDMS), manufacturing execution systems (MES), and regulatory compliance software.
• Collaborate closely with cross-functional teams including IT, quality assurance, regulatory affairs, and manufacturing to ensure alignment of computer system validation activities with business objectives and regulatory requirements.
• Perform risk assessments and gap analyses to identify areas for improvement in computer system validation processes and procedures.
• Develop and implement strategies for maintaining validated status of computerized systems throughout their lifecycle, including periodic reviews, change control, and revalidation activities.
• Provide expertise and guidance on CSV best practices, industry standards, and regulatory requirements (e.g., FDA 21 CFR Part 11, EU GMP Annex 11).
• Lead and participate in audits and inspections related to computer system validation activities, and drive closure of any identified corrective and preventive actions (CAPAs).
• Stay current with emerging technologies and trends in the life science industry, and assess their potential impact on CSV processes and systems.

Qualifications:

• Bachelor’s or Master’s degree in computer science, engineering, life sciences, or a related field.
• Minimum of 3-5 years of experience in computer system validation within the life science industry, preferably in a regulated environment (e.g., pharmaceuticals, biotechnology, medical devices).
• Strong understanding of regulatory requirements and guidelines related to computer system validation, including FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP.
• Experience with validation of various types of computerized systems, including LIMS, EDMS, MES, and regulatory compliance software.
• Proficiency in risk management methodologies and tools, and experience conducting risk assessments for computerized systems.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and stakeholders.
• Strong analytical and problem-solving skills, with a keen attention to detail.
• Experience with project management methodologies and tools is a plus.

We offer :

• A competitive salary and benefits package.
• Opportunities for professional growth and development.
• A collaborative and inclusive work environment.
• Participation in cutting-edge projects in the pharma industry.

How to apply :

Interested candidates are invited to submit their CV this form. Please include references and any relevant project details in your application.