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Implementation Specialist (Configuration)

Remote · Japan Full-time

This is a remote position. 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 The Implementation Specialist (Configuration) is responsible for leading and supporting the configuration, implementation, validation, and customer enablement activities associated with PSC Software’s ACE® platform and related software solutions within regulated life sciences environments. Within this role you will serve as a trusted advisor throughout software implementation projects and collaborate closely with Project Managers, Product Managers, Technical Support, Validation teams, Software Developers, Data Migration specialists, and customer Subject Matter Experts (SMEs) to ensure successful project delivery and long-term customer success. Configure ACE® and related PSC Software solutions to align with customer business processes, compliance requirements, and project scope. Lead or support customer workshops, requirements gathering sessions, configuration reviews, and solution demonstrations. Translate customer requirements into scalable software configurations and workflow designs. Configure and maintain forms, workflows, permissions, metadata, document lifecycles, training workflows, quality processes, and related system functionality. Support implementation planning, deployment activities, go-live readiness, and Hypercare support activities. Support Computer Software Assurance (CSA) and Computer System Validation (CSV) activities associated with regulated software implementations. Assist with development and execution of validation documentation. Ensure implementation activities align with applicable regulatory and data integrity expectations Conduct customer training sessions, workshops, and knowledge transfer activities. Provide guidance regarding system administration, best practices, operational workflows, and regulated system usage. Support customer adoption and long-term operational success. Collaborate closely with Project Managers to support project timelines, deliverables, risks, and customer communications. Work with Product Management and Software Development teams to communicate enhancement requests, product gaps, and customer feedback. Partner with Technical Support and Customer Success teams during escalations, Hypercare activities, and post-go-live support. Coordinate with Data Migration and Integration specialists as required for implementation activities. Troubleshoot configuration, workflow, validation, and operational issues during implementations. Support software testing, deployment verification, and production readiness activities. Assist with proof-of-concept environments, internal demos, and pre-sales support activities when needed. Maintain implementation documentation and customer records according to PSC Software procedures and quality standards.

Requirements

Bachelor’s degree in Life Sciences, Computer Science, Information Systems, Engineering, or related discipline preferred. Minimum 5 years of experience in software implementation, configuration, validation, technical consulting, or related customer-facing software roles. Minimum 3 years of experience supporting regulated life sciences, pharmaceutical, biotechnology, medical device, or GxP environments preferred. Experience configuring enterprise SaaS platforms, eQMS systems, EDMS systems, LMS systems, or similar regulated software solutions. Strong understanding of regulated business processes and software validation concepts. Experience conducting customer workshops, training sessions, and requirements gathering activities. Strong written and verbal communication skills. Excellent troubleshooting, organizational, and problem-solving abilities. Ability to manage multiple projects and competing priorities in a fast-paced environment. Experience working with global customers and distributed teams preferred. Ability to work flexible hours as needed to support overlap with North American and Australian customers.

Benefits

Equal Opportunity Employment Statement PSC Software 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​

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