CSV Engineer
AL Solutions, Switzerland
Job Description
Are you a talented CSV Engineer with a strong background in GCP (Good Clinical Practice)? Are you seeking an exciting opportunity to contribute to the success of a renowned pharmaceutical company? Look no further! I have the perfect position for you.
I am partnered with a well-established pharmaceutical company located in Switzerland, dedicated to improving the lives of patients worldwide. With our commitment to innovation, quality, and patient safety, They have earned a reputation as a leader in the industry. As we continue to expand our operations, They are seeking a highly skilled CSV Engineer to join our dynamic team.
Location: Switzerland (flexible work arrangements available)
Job Type: Contract or Permanent
Responsibilities:
- Collaborate with cross-functional teams to ensure compliance with GCP regulations and guidelines.
- Develop and execute validation strategies for computerized systems, including GCP-related applications.
- Create and maintain validation documentation, such as validation plans, protocols, and reports.
- Perform risk assessments and impact analyses to identify potential compliance issues and recommend mitigation strategies.
- Conduct CSV activities for various systems, ensuring adherence to industry standards and regulatory requirements.
- Provide technical expertise and guidance on CSV-related matters to project teams and stakeholders.
- Participate in audits and inspections, supporting the resolution of any findings related to CSV activities.
Qualifications:
- Bachelor's or Master's degree in Computer Science, Engineering, or a related field.
- Strong experience as a CSV Engineer, preferably within the pharmaceutical or life sciences industry.
- Expertise in GCP regulations and guidelines, with a solid understanding of computer system validation principles.
- Proficiency in implementing CSV processes and methodologies.
- Hands-on experience with GCP-related applications, such as clinical trial management systems, electronic data capture (EDC) systems, and electronic document management systems (eDMS).
- Familiarity with cloud platforms, particularly Google Cloud Platform (GCP).
- Excellent problem-solving skills and ability to analyse complex issues.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders.
- Fluency in English; knowledge of German and/or French is a plus
Benefits:
- Competitive salary and comprehensive benefits package.
- Access to cutting-edge technologies and a collaborative work environment.
- Professional development and growth opportunities.
- Work-life balance and flexible working hours.
How To Apply
AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.
Ashley Smith-Brown
Tel: +44 (0) 203 778 0909