CSV Professional

PSC Software, a division of PSC Biotech, is a leading provider of cutting-edge, cloud-based quality management and regulatory compliance solutions. Our software helps organizations streamline processes, ensure compliance, and improves overall efficiency, delivering exceptional value to our clients. With specialization in meeting the needs of pharmaceutical, medical device, and other highly regulated industries.

At PSC Software, we are passionate about providing innovative software solutions that empower businesses to achieve their full potential.

The Experience

With operations spanning the globe and featuring a multicultural team, PSC Biotech® is passionate about bringing the best and brightest together to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

We are looking for a Computer System Validation Professional. This role will work alongside a talented PSC Team, and works under the leadership of one of the best in the industry! Successful candidates will have excellent verbal and written communication skills, an understanding of the IT realm, and a thirst to learn! This is a remote role that will operate across U.S time zones.

• Keep up to date with advances in the field and the regulatory requirements.
• Maintain comprehensive knowledge of ACE features.
• Maintain comprehensive knowledge of Katalon/Selenium automated software testing tools.
• Author, review, approve, revise, and execute computer system validation (CSV) deliverables and ensure they meet regulatory requirements and quality standards.
• Author, review, revise, and approve data migration documents and perform random sampling to ensure statistical confidence levels in the data migrated into or exported from ACE.
• Create, revise, execute, and review Katalon/Selenium automated tests for ACE workflows.
• Prioritize ACE Enterprise implementation work for customers, but also assist with validation of core ACE functionality (IOQ), ACE Essentials, BioTechnique, and other internal projects.
• Author and revise SOPs and training materials as needed.
• Provide estimated validation hours for projects.
• Provide guidance for validation deliverables and strategies.
• Additional duties and responsibilities may be assigned from time-to-time.