CSV Application Engineer

About the role

As a CSV Application Engineer at Bamboohr, you will play a pivotal role in ensuring that our computerized systems comply with regulatory standards and meet operational excellence. This position is crucial for maintaining the integrity of our systems and processes, which are essential in the pharmaceutical industry. You will collaborate with cross-functional teams to implement and validate software applications, ensuring they are fit for purpose and compliant with industry regulations. Your expertise will help drive continuous improvement initiatives and enhance our overall quality management system.

Key facts

What you'll do

• Collaborate with project teams to define and document the requirements for computerized systems in compliance with regulatory standards such as GxP and FDA guidelines.
• Develop and execute validation protocols for software applications, ensuring that they meet the necessary specifications and performance criteria.
• Conduct risk assessments and impact analyses to identify potential compliance issues and propose effective solutions.
• Prepare and maintain comprehensive documentation, including validation plans, test scripts, and reports, to ensure traceability and compliance.
• Participate in audits and inspections, providing necessary documentation and support to demonstrate compliance with regulatory requirements.
• Provide training and support to team members on CSV processes, tools, and best practices to foster a culture of quality and compliance.
• Collaborate with IT and quality assurance teams to ensure that all systems are maintained and updated in accordance with validation requirements.
• Monitor industry trends and regulatory changes to ensure that Bamboohr's CSV practices remain current and effective.
• Assist in the development of standard operating procedures (SOPs) related to CSV and ensure they are adhered to across the organization.
• Engage in continuous improvement initiatives to streamline validation processes and enhance overall efficiency.
• Troubleshoot and resolve issues related to computerized systems, ensuring minimal disruption to operations.
• Support the implementation of new technologies and systems, ensuring they are validated and compliant before going live.

Requirements

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
• A minimum of 3 years of experience in Computer System Validation (CSV) within the pharmaceutical or biotechnology industry.
• Strong understanding of regulatory requirements related to CSV, including GxP, FDA, and EMA guidelines.
• Proven experience in developing validation documentation, including protocols, reports, and SOPs.
• Excellent analytical and problem-solving skills, with the ability to assess risks and propose effective solutions.
• Strong communication skills, both verbal and written, with the ability to convey complex information clearly to diverse audiences.
• Proficient in using validation tools and software, as well as Microsoft Office Suite.
• Ability to work independently and as part of a team in a fast-paced environment.
• Detail-oriented with a strong commitment to quality and compliance.

Nice to have

• Experience with electronic laboratory notebooks (ELN) and laboratory information management systems (LIMS).
• Knowledge of project management methodologies and tools.
• Familiarity with software development life cycle (SDLC) and agile methodologies.
• Certification in quality assurance or validation (e.g., ASQ, ISPE).
• Multilingual capabilities, particularly in Turkish and English, are a plus.

Skills & tools

• Proficient in Computer System Validation methodologies and best practices.
• Familiarity with risk management techniques and tools.
• Knowledge of data integrity principles and practices.
• Strong project management skills and experience with relevant software tools.
• Excellent organizational skills and the ability to manage multiple projects simultaneously.

Practical notes

• This position is based in Turkey, and candidates must be eligible to work in the country.
• The salary for this role will be competitive and commensurate with experience.
• Bamboohr is committed to diversity and inclusion and encourages applications from all qualified candidates.
• Interested applicants can apply through the following link: [Bamboohr Careers](https://acino.bamboohr.com/careers/890).

META

Company: Bamboohr

Title: CSV Application Engineer

Listed

location: Turkey

Job type: Active