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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Global QC Labs Application Engineer - Manufacturing Systems - **Company:** Astellas Pharma - **Location:** Sanford, NC, United States (Remote available) - **Experience:** Expert - **Salary:** $125,090.0 - $178,700.0 - **Contract:** Permanent contract - **Skills:** Agile Methodology, Business Systems, Configuration Management Databases, Continuous Delivery, Continuous Integration, Data Systems, DevOps, Python (Programming Language), Laboratory Information Management Systems, SAP (Applications), PL-SQL, Data Streaming, Technical Data Management Systems, Data Lakes, Information Technology, Qlikview, GXP, User Administration, Databricks - **Published:** August 29, 2026 - **Apply:** https://www.careerjet.com/job/usc7730885313f8c87e0755651f78399b2/eaa ## About the Role * Bachelor's degree in relevant biotech area (e.g. pharmaceutical- and bio technology) * Minimum of 5+ years demonstrated experience in the scientific IT area, preferably in pharma/biotech environments * Mandatory experience in CDS (Empower), LIMS (Labware) and SDMS lab systems * Knowledge of manufacturing processes, equipment qualification and computer systems validation (CSV) according to GAMP 5 principles is a must. * Strong analytical and problem-solving skills * Ability to work effectively in a team environment * Excellent communication skills, both written and verbal (English (or English/Japanese for JP region) * Agile and adaptable to changing environments and initiative scopes * Demonstrated experience working with business to define Epics/user stories/features, as well as conducting impact analysis * Able to support technical upgrade by conducting impact assessment, addressing any issues, support testing, and document changes per the System Life Cycle (SLC) processes in Astellas. * Maintain CMDB for each of the relevant systems * Support system deliverables and provide technical and functional feedback during internal and external system audits * Work closely with the internal privacy and security team to assess personal Information requests and act according per the privacy laws applicable to the region. * Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during technical upgrades * Lead without authority and be escalation point for any customer issues * Resolve conflicts and provide mediation in service disputes between suppliers and Astellas * Ability to manage critical problem and outage situations under extreme pressure * Experience with vendor management for high value / high impact contracts * Excellent people management skills over technical, service delivery and operational staff * Ensure that business and IT needs are clearly articulated for effective delivery. * Act as system owner for relevant QC systems, responsible for keeping the systems in validated state. * Experience maintaining relationship with suppliers and maintain the relevant budgets Preferred Qualifications * Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery * Preferred knowledge in PL/SQL, Python, Qlik and Databricks * Present technical and/or functional solutions based on the business requirement of the Manufacturing system. * Significant experience in developing and configuring with Empower, LIMS Software and QC Lab Solutions ## Description A Global QC Labs Application Engineer is the Subject Matter Expert focused on the system administration, maintenance and enhancements to facilitate changes to laboratory systems and business processes in a complex Scientific IT landscape to ensure proper operation of GxP and non-GxP systems. Typical systems like Chromatography Data Systems (CDS), Scientific Data Management Systems (SDMS), Laboratory Information Management Systems (LIMS), Electronic Lab Notebook (ELN) and capacity management and resource scheduling systems within the Manufacturing QC labs are part of your knowledge, experience and skillset. This role is responsible for the configuration, maintenance, integration, and support of laboratory systems to ensure compliance, efficiency, and reliability in a regulated (GxP) environment, with openness to hiring motivated individuals who are eager to learn. Role and Responsibilities * Be the first point of contact for key users in the QC labs of the lab systems and provide technical support, triage issues and requests * Work closely together with your direct colleagues and team members to support multiple QC labs globally. * Be the subject-matter expert for the lab systems during inspections and audits. * Be responsible for administration, maintenance and user management (e.g. create and manage roles, and support user access review request) of lab systems such as Labware LIMS, Waters Empower, ELN and Binocs . * Facilitate and/or initiate enhancements and changes to the lab systems in close collaboration with the vendor. * Conduct training sessions to users to ensure proper use of the laboratory systems. * Regularly monitor the performance of the lab systems, identify bottlenecks, and implement optimizations to improve efficiency and user experience. * Ensure seamless integration in between the lab systems (e.g. LIMS and Empower) and with other business systems (e.g. LIMS with Data Lakes and ERP (SAP) systems) to enhance data flow and business processes. * Manage and ensure proper operation of GxP and non-GxP lab systems by adhering to Astellas global and local procedures and guidelines. * Work collaboratively with team members within the subdivision and across other digital and business units * Actively participate in and contribute to various initiatives like process improvements and set up/improve the Scientific IT landscape * Contribute to the ongoing realization of Value from these lab systems through continuous integration and deployment. * Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in the specific area of expertise. * Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities. * Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions, $125,090 - $178,700 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.) ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [From DevOps to Scaled DevOps: How We’re Rebuilding Continuous Delivery as a Platform](https://www.wearedevelopers.com/videos/100018-from-devops-to-scaled-devops-how-we-re-rebuilding-continuous-delivery-as-a-platform) - [Remote Driving on Plant Grounds with State-of-the-Art Cloud Technologies](https://www.wearedevelopers.com/videos/251-remote-driving-on-plant-grounds-with-state-of-the-art-cloud-technologies) - [DevOps Maturity Check – a way to balance autonomy and alignment](https://www.wearedevelopers.com/videos/58-devops-maturity-check-a-way-to-balance-autonomy-and-alignment) - [#90DaysOfDevOps - The DevOps Learning Journey](https://www.wearedevelopers.com/videos/548-90daysofdevops-the-devops-learning-journey) - [Navigating the Corporate Jungle: Life as a Developer in a large Company](https://www.wearedevelopers.com/videos/621-navigating-the-corporate-jungle-life-as-a-developer-in-a-large-company) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers) - [The Fastest-Growing Tech Sectors to Look Out for in 2025](https://www.wearedevelopers.com/magazine/373-the-fastest-growing-tech-sectors-to-look-out-for-in-2025) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [Best Companies to Work For in Germany: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/33-best-companies-to-work-for-in-germany-top-25-companies-in-2023)