Director Computer System Validation Csv Jobs (NOW HIRING)

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 The LabWare Specialist is responsible for the configuration, integration, and validation of LabWare LIMS within a GMP-regulated laboratory environment.

This role supports end-to-end LIMS implementation activities, including translating regulatory, quality, and operational requirements into compliant system designs, executing configuration builds, integrating laboratory instruments and enterprise systems, and supporting validation deliverables. The ideal candidate is a hands-on contributor with strong expertise in LabWare configuration, instrument integrations (e.g., Empower, LabX), and Computer System Validation (CSV), ensuring stable, compliant execution of laboratory workflows across raw materials and commercial product testing. LabWare Configuration Configure LabWare LIMS for raw materials, commercial products, stability programs, and laboratory equipment workflows

Develop and maintain master data, test methods, sampling plans, and product specifications. Apply standardized, compliant configuration design patterns to ensure scalability, consistency, and regulatory adherence. Support method configuration within LabWare aligned to approved laboratory processes.

System & Instrument Integration Design, configure, and support integrations between LabWare LIMS and laboratory instrumentation (e.g., Empower, LabX). Enable data flow between LabWare and enterprise GMP systems. Support or develop parsing scripts/interfaces in alignment with system governance and standards

Troubleshoot integration issues and ensure reliable system connectivity and performance. Validation & CSV Support Support Computer System Validation (CSV) activities for LabWare implementations and enhancements. Author and/or contribute to validation deliverables.

Ensure full requirements-to-configuration traceability. Support audit readiness and ensure compliance with GxP, data integrity, and regulatory requirements. Requirements Translation & Design Gather and translate regulatory, quality, and operational requirements into standardized LabWare system designs.

Ensure configurations align with approved test methods, specifications, and laboratory procedures. Partner with quality, validation, IT, and laboratory teams to ensure solutions are fit for intended use. Operational Support & Execution Support deployment, go-live readiness, and steady-state operations of LabWare systems.

Troubleshoot configuration and workflow issues impacting laboratory operations. Ensure stable execution of laboratory workflows in a GMP environment. Provide ongoing system support and continuous improvement recommendations.

Cross-Functional Collaboration Collaborate with Quality, Validation, IT, and Laboratory stakeholders throughout implementation and support phases. Participate in requirements workshops, system design reviews, and testing activities. Support project timelines and deliverables as an individual contributor.

Requirements Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field preferred. 5+ years of hands-on experience with LabWare LIMS (LabWare 8 preferred) in GMP/GxP environments. Strong expertise in configuration of raw materials, commercial product, stability, and laboratory workflows.

Experience integrating LabWare with laboratory systems (e.g., Empower, LabX) and supporting data interfaces. Proven experience supporting Computer System Validation (CSV) and authoring validation documentation (e.g., URS, IQ/OQ/PQ, traceability). Solid understanding of GMP, GxP, data integrity, and validation lifecycle requirements

Strong troubleshooting, problem-solving, and cross-functional communication skills. Experience with LIMS upgrades, large-scale implementations, and/or inspection readiness is preferred. Must be authorized to work in the U.S

No C2C at this time. Benefits W2 Temp roles include our Medical and Sick Time benefits. Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $85,000 - $115,000 annually.

The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC Biotech 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-RD1.