CSV Professional

Job Description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort 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 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 would work alongside an amazingly 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!

• 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

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.

#LI-DC1

Requirements

TECHNICAL SKILLS FOR AUTOMATION ENGINEERS : Basic Skills : Design, author, document, maintain, and execute automated software test scripts used for regression and functional testing cycles. Write test cases in groovy, XML, Java and other front-end languages with the Katalon interface. Delivers execution documentation and accurately reports and documents issues during the execution. (JIRA, Deviation, etc.) Perform dry run and technical review of automation report and validation documents. Understand and communicate with development team on software problems 3 of 7 and development process. Understand and conduct validation process. Work with Katalon, version control tool, and any other software that is used for automation tests. Maintain current knowledge and implementation of cGMP (cGxP). Know and apply 21 CFR Part 11 compliance. Practice Good Documentation Practices. Understand and know workflow functionality and all modules of ACE well. Identify and author Requirement Specifications on basic features. Perform risk assessment on Requirement Specifications and JIRAs. Intermediate Skills : Create and design new keywords and complicated pathways using automation tool. Be able to debug and find code issues. Train others on Basic Skills. Understand and know obscure features of ACE. Identify and communicate Requirement Specifications for Epic features. Complete tasks with minimum oversight. Perform branch merging and resolve conflicts in automation code. Advanced Skills : Understand and know niche configurations with ACE such as API, Single Sing On, SCORM. Know the backend database structure from discussions with development. Integrate ACE, Katalon, or other software being used with their party tools. Improve the automation tool through research and development. Being an expert in a feature or obscure function in the application. Train others on Intermediate Skills. Complete tasks with no oversight. Develop Automation Infrastructure. Required Skills and Education : College Degree in STEM Major or equivalent. Experience programming a plus. Experience with a scripting language a plus. Experience with HTML 5, CSS 3 or other Front end Web 2.0 technologies a plus. Experience with Selenium or other automation tool a plus. 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. #LI-FF1