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CSV Professional

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Manila, National Capital Region, Philippines PSC Biotech® Corporation Full time

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.

Requirements

  • Bachelors Degree in Computer Science or related field.
  • Must have strong written and verbal communication skills.
  • Previous experience with Katalon and XPath is preferred.
  • Previous experience in the IT industry is preferred.
  • Previous experience in Pharma, Life Science, GxP industries is preferred.
  • Must be adaptable, customer service oriented, have a positive attitude.
  • Must be able to work in a remote setting across U.S Time zones

**Equal Opportunity Employment Statement:

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.**